Dental Device Classification Codes
12198 FDA 510(k) clearances across 329 product codes.
DZE
Class 2
EBF
Class 2
Material, Tooth Shade, Resin
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NHA
Class 2
Abutment, Implant, Dental, Endosseous
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EJT
Class 2
Alloy, Gold-Based Noble Metal
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EMA
Class 2
Cement, Dental
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EIH
Class 2
Powder, Porcelain
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KLE
Class 2
Agent, Tooth Bonding, Resin
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ELW
Class 2
Material, Impression
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EBI
Class 2
Resin, Denture, Relining, Repairing, Rebasing
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JEY
Class 2
Plate, Bone
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EIA
Class 1
Unit, Operative Dental
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EFB
Class 1
Handpiece, Air-Powered, Dental
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LYC
Class 2
Bone Grafting Material, Synthetic
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EBZ
Class 2
Activator, Ultraviolet, For Polymerization
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LRK
Class 2
Device, Anti-Snoring
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EJS
Class 2
Alloy, Other Noble Metal
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DYH
Class 2
Adhesive, Bracket And Tooth Conditioner, Resin
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EHD
Class 2
Unit, X-Ray, Extraoral With Timer
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MUH
Class 2
System, X-Ray, Extraoral Source, Digital
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ELC
Class 2
Scaler, Ultrasonic
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EBG
Class 2
Crown And Bridge, Temporary, Resin
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EJH
Class 2
Alloy, Metal, Base
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NXC
Class 2
Aligner, Sequential
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KIF
Class 2
Resin, Root Canal Filling
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LBH
Class 2
Varnish, Cavity
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EBC
Class 2
Sealant, Pit And Fissure, And Conditioner
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EJF
Class 1
Bracket, Metal, Orthodontic
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EKX
Class 1
Handpiece, Direct Drive, Ac-Powered
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DZL
Class 2
Screw, Fixation, Intraosseous
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EJR
Class 1
Agent, Polishing, Abrasive, Oral Cavity
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EJJ
Class 2
Alloy, Amalgam
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EJK
Class 2
Liner, Cavity, Calcium Hydroxide
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EKJ
Class 1
Burnisher, Operative
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EGS
Class 1
Handpiece, Contra- And Right-Angle Attachment, Dental
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KLC
Class 1
Chair, Dental, With Operative Unit
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JES
Class 1
Floss, Dental
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MQN
Class 2
External Mandibular Fixator And/Or Distractor
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EBW
Class 1
Controller, Foot, Handpiece And Cord
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NJM
Class 2
Bracket, Ceramic, Orthodontic
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ELM
Class 2
Denture, Plastic, Teeth
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JEQ
Class 1
Toothbrush, Powered
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EBD
Class 2
Coating, Filling Material, Resin
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NPL
Class 2
Barrier, Animal Source, Intraoral
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OAT
Class 2
Implant, Endosseous, Orthodontic
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EFW
Class 1
Toothbrush, Manual
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KOJ
Class 2
Airbrush
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EFS
Class 1
Unit, Oral Irrigation
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DZI
Class 2
Drill, Bone, Powered
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EJI
Class 2
Syringe, Cartridge
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EAP
Class 2
Unit, X-Ray, Intraoral
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DYW
Class 2
Bracket, Plastic, Orthodontic
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ELL
Class 2
Teeth, Porcelain
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DZB
Class 2
Headgear, Extraoral, Orthodontic
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ELR
Class 1
Post, Root Canal
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NPM
Class 2
Bone Grafting Material, Animal Source
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PNN
Class 2
Orthodontic Software
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EIE
Class 1
Dam, Rubber
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EKS
Class 1
File, Pulp Canal, Endodontic
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LCN
Class 1
Scraper, Tongue
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DZC
Class 1
Wire, Orthodontic
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EBH
Class 1
Material, Impression Tray, Resin
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DZJ
Class 2
Driver, Wire, And Bone Drill, Manual
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NPK
Class 2
Barrier, Synthetic, Intraoral
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EJL
Class 1
Bur, Dental
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KKO
Class 2
Ring, Teething, Fluid-Filled
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LQZ
Class 2
Device, Jaw Repositioning
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EFT
Class 1
Cleanser, Denture, Over The Counter
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ECI
Class 1
Band, Elastic, Orthodontic
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EGD
Class 1
Wax, Dental, Intraoral
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EFA
Class 1
Handpiece, Belt And/Or Gear Driven, Dental
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EGG
Class 1
Attachment, Precision, All
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EAZ
Class 1
Light, Operating, Dental
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EKM
Class 1
Gutta-Percha
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NBL
Class 2
Light-Induced Fluorescence Caries Detector
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EAT
Class 2
Tester, Pulp
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PLV
Class 2
Dental Stereotaxic Instrument
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DZP
Class 1
Instrument, Diamond, Dental
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EIS
Class 1
Remover, Crown
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EKZ
Class 2
Unit, Electrosurgical, And Accessories, Dental
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DYN
Class 1
Mouthpiece, Saliva Ejector
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EAY
Class 1
Light, Fiber Optic, Dental
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EHZ
Class 1
Evacuator, Oral Cavity
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LFC
Class 2
Device, Caries Detection
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DZM
Class 1
Needle, Dental
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DZN
Class 1
Instruments, Dental Hand
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EHY
Class 1
Tray, Impression, Preformed
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EIC
Class 1
Syringe, Periodontic, Endodontic, Irrigating
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EFD
Class 1
Amalgamator, Dental, Ac-Powered
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JET
Class 1
Pick, Massaging
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EFN
Class 1
Cotton, Roll
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JER
Class 1
Cleaner, Denture, Mechanical
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NUN
Class 2
Bone Grafting Material, Human Source
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DZA
Class 1
Drill, Dental, Intraoral
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EID
Class 1
Syringe, Restorative And Impression Material
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EAX
Class 1
Mirror, Mouth
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ECB
Class 1
Unit, Syringe, Air And/Or Water
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EEG
Class 1
Heat Source For Bleaching Teeth
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KMY
Class 1
Positioner, Tooth, Preformed
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NTK
Class 2
Light Transmission Caries Detector
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DYX
Class 2
Lock, Wire, And Ligature, Intraoral
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EBL
Class 1
Pin, Retentive And Splinting, And Accessory Instruments
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EGM
Class 2
Injector, Jet, Mechanical-Powered
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EJP
Class 1
Articulators
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EMB
Class 1
Zinc Oxide Eugenol
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NXV
Class 2
Diagnostic Light, Soft Tissue Detector
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EAG
Class 2
Cephalometer
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EBA
Class 1
Light, Surgical Headlight
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EFH
Class 1
Paper, Articulation
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EMG
Class 1
Forceps, Tooth Extractor, Surgical
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KHR
Class 1
Absorber, Saliva, Paper
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EIX
Class 1
Probe, Periodontic
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ELZ
Class 1
Crown, Preformed
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KMW
Class 2
Handpiece, Rotary Bone Cutting
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ORY
Class 2
Tongue Suspension System
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PLC
Class 2
Sleep Appliances With Patient Monitoring
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DZD
Class 1
Tube, Orthodontic
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EGZ
Class 1
Holder, Film, X-Ray
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EHK
Class 1
Cup, Prophylaxis
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EHP
Class 1
Clasp, Preformed
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EIG
Class 1
Retractor, All Types
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EIL
Class 1
Gauge, Depth, Instrument, Dental
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EMH
Class 1
Forceps, Rongeur, Surgical
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KMT
Class 1
Tray, Fluoride, Disposable
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KOT
Class 1
Carboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-Sodium
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PNP
Class 2
Dental Abutment Design Software For Dental Laboratory
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EBO
Class 2
Denture Repair Kit
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ECG
Class 1
Sterilizer, Boiling Water
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ECO
Class 1
Spring, Orthodontic
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EGN
Class 1
Scissors, Surgical Tissue, Dental
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EJB
Class 1
Handle, Instrument, Dental
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EKN
Class 1
Point, Paper, Endodontic
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EKW
Class 1
Broach, Endodontic
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EMS
Class 1
Curette, Periodontic
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JEX
Class 1
Plier, Orthodontic
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PHR
Class 2
Diammine Silver Fluoride Dental Hypersensitivity Varnish
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EKP
Class 1
Reamer, Pulp Canal, Endodontic
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EKR
Class 1
Plugger, Root Canal, Endodontic
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ELB
Class 2
Scaler, Rotary
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ELS
Class 2
Splint, Endodontic Stabilizing
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EMJ
Class 1
Elevator, Surgical, Dental
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NEI
Class 2
Prosthesis, Condyle, Mandibular, Temporary
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DYJ
Class 1
Retainer, Screw Expansion, Orthodontic
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EFL
Class 1
Forceps, Dressing, Dental
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EHB
Class 1
Collimator, X-Ray
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EIK
Class 1
Carver, Wax, Dental
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EIY
Class 1
Instrument, Filling, Plastic, Dental
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EMN
Class 1
Scaler, Periodontic
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MCF
Class 1
Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Sterile
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MXF
Class 2
System, Dental, Hydrokinetic, Caries Removal & Cavity Preparation
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MYB
Class 2
Pillow, Cervical (For Mild Sleep Apnea)
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NEA
Class 2
Cement, Ear, Nose And Throat
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NRQ
Class 2
Blade-Form Endosseous Dental Implant
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OHP
Class 2
Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea
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OYH
Class 2
Orthodontic Vibratory Accessory
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OZR
Class 2
Intraoral Pressure Gradient Device
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QRY
Class 2
Dental Navigation System
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DYT
Class 1
Maintainer, Space Preformed, Orthodontic
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DZH
Class 2
Saw, Bone, Ac-Powered
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DZS
Class 1
Capsule, Dental, Amalgam
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EHJ
Class 1
Disk, Abrasive
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EHL
Class 1
Point, Abrasive
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EIB
Class 1
Syringe, Irrigating (Dental)
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EIF
Class 1
Accessories, Retractor, Dental
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EKO
Class 2
Denture Preformed (Partially Prefabricated Denture)
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ELA
Class 1
Instrument, Hand, Calculus Removal
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ELE
Class 2
Implant, Subperiosteal
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ELY
Class 2
Mercury
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EMI
Class 1
File, Bone, Surgical
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EMM
Class 1
Chisel, Osteotome, Surgical
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KOO
Class 1
Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt
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KOQ
Class 1
Adhesive, Denture, Carboxymethylcellulose Sodium (40-100&)
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NDP
Class 1
Accessories, Implant, Dental, Endosseous
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NFQ
Class 1
Device, Dental Sonography, For Monitoring Jaw Sounds
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NOF
Class 2
System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations
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NYL
Class 1
Handpiece, Air-Powered, Root Canal Irrigation
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DYO
Class 1
Band, Material, Orthodontic
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EBE
Class 2
Coating, Denture Hydrophilic, Resin
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EBP
Class 2
Reliner, Denture, Over The Counter
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EBR
Class 1
Unit, Suction Operatory
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ECR
Class 1
Setter, Band, Orthodontic
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EEF
Class 1
Clamp, Rubber Dam
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EHO
Class 1
Bar, Preformed
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EHS
Class 2
Cushion, Denture, Over The Counter
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EJE
Class 1
Frame, Rubber Dam
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EJW
Class 1
Clasp, Wire
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EKB
Class 1
Explorer, Operative
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EKG
Class 1
Condenser, Amalgam And Foil, Operative
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EKH
Class 1
Carver, Dental Amalgam, Operative
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EKL
Class 1
Point, Silver, Endodontic
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EME
Class 1
Punch, Biopsy, Surgical
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JEP
Class 1
Retainer, Matrix
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JEW
Class 1
Tip, Rubber, Oral Hygiene
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KXR
Class 1
Applicator, Resin
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SHI
Class 2
Impression Material For Fabrication Of Patient-Matched Mouthguards, Over-The-Counter
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DZK
Class 2
Wire, Fixation, Intraosseous
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EAH
Class 1
Cone, Radiographic, Lead-Lined
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EAQ
Class 2
Detector, Ultraviolet
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ECM
Class 1
Band, Preformed, Orthodontic
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ECQ
Class 1
Aligner, Bracket, Orthodontic
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ECS
Class 1
Pusher, Band, Orthodontic
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EHE
Class 1
Dispenser, Mercury And/Or Alloy
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EHM
Class 1
Strip, Polishing Agent
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EJY
Class 1
Pliers, Operative
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EJZ
Class 1
Knife, Margin Finishing, Operative
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EKA
Class 1
File, Margin Finishing, Operative
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EKC
Class 1
Excavator, Dental, Operative
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EKD
Class 1
Instrument, Cutting, Operative
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EKI
Class 1
Carrier, Amalgam, Operative
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EKQ
Class 1
Preparer, Root Canal Endodontic
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EKY
Class 1
Handpiece, Water-Powered
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ELK
Class 1
Teeth, Artificial, Backing And Facing
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EMD
Class 1
Hemostat, Surgical
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EML
Class 1
Chisel, Bone, Surgical
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KOL
Class 1
Adhesive, Denture, Carboxymethylcellulose Sodium (32%) And Ethylene-Oxide Homopolymer
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KZN
Class 2
Scanner, Color
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KZO
Class 1
Ink, Arch Tracing
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KZP
Class 2
Solution, Cement Dissolving
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LTF
Class 2
Stimulator, Salivary System
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MAU
Class 1
Eraser, Dental Stain
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MDL
Class 2
Implant, Transmandibular
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MMD
Class 1
Toothbrush, Ionic, Battery-Powered
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MZW
Class 2
Dental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering For Pain Relief
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NFS
Class 1
Device, Jaw Tracking, For Monitoring Jaw Positions
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NRD
Class 1
Unit, Operative Dental, Accessories
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OIV
Class 2
Dental Amalgam
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PME
Class 2
External Cleaning Solution
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POW
Class 2
Crown And Bridge, Long-Term Temporary, Resin
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QNF
Class 2
Laser Activator For Polymerization
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QNO
Class 2
Neuromuscular Tongue Muscle Stimulator For The Reduction Of Snoring And Obstructive Sleep Apnea
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QTT
Class 2
Over The Counter Electrical Salivary Stimulatory System
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EEJ
Class 1
Guard, Disk
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EGI
Class 1
Parallelometer
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EGQ
Class 2
Injector, Jet, Gas-Powered
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EHA
Class 1
Aligner, Beam, X-Ray
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EIR
Class 1
Scissors, Collar And Crown
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EIT
Class 2
Applicator, Rapid Wax, Dental
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EJG
Class 1
Forceps, Rubber Dam Clamp
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EJQ
Class 1
Wheel, Polishing Agent
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EKK
Class 1
Spreader, Pulp Canal Filling Material, Endodontic
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ELN
Class 1
Teeth, Preformed Gold Denture
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EMK
Class 1
Curette, Surgical, Dental
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EMR
Class 1
File, Periodontic
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KCQ
Class 1
Tube Impression And Matrix
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KCR
Class 1
Facebow
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KOM
Class 1
Adhesive, Denture, Acacia And Karaya With Sodium Borate
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KOP
Class 1
Adhesive, Denture, Karaya
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KXX
Class 1
Adhesive, Denture, Karaya And Ethylene-Oxide Homopolymer
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MEF
Class 1
Ring, Teething, Non-Fluid Filled
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NTO
Class 2
Rinse, Oral, Antibacterial (By Physical Means)
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NYH
Class 2
Plaque Disclosing Kit
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PFL
Class 1
Intraoral, Dental Foam Protector
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PIP
Class 2
Prophy Powder, Airbrush Accessory
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PLH
Class 2
Orthodontic Led Accessory
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PZY
Class 2
Additively Manufactured, Preformed, Resin Denture Tooth
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QGO
Class 1
Composite Resin Warmer
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QIA
Class 1
Powered Tongue Scraper
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QJC
Class 1
Plaque Disclosing Agent
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QMJ
Class 2
Powered Radiofrequency Toothbrush
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QUA
Class 2
Intraoral Cooling Device
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QYJ
Class 1
Dental Waterline Treatment Cartridge
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SHQ
Class 2
Dental Image Analyzer, In-Office
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SJH
Class 1
Portable Dental Operative Unit
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EAS
Class 1
Gel, Electrode, For Pulp Tester
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ECC
Class 3
Sterilizer, Glass Bead
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ECN
Class 1
Clamp, Wire, Orthodontic
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ECP
Class 1
Instrument, Ligature Tucking, Orthodontic
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ECT
Class 1
Driver, Band, Orthodontic
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EEA
Class 1
Plate, Base, Shellac
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EFC
Class 1
Warmer, Anesthetic Tube
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EFK
Class 1
Forceps, Articulation Paper
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EFX
Class 1
Protector, Silicate
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EHQ
Class 1
Cusp, Preformed
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EHR
Class 2
Pad, Denture, Over The Counter
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EJX
Class 1
Anchor, Preformed
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EKE
Class 1
Curette, Operative
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EKF
Class 1
Instrument, Contouring, Matrix, Operative
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EKT
Class 1
Curette, Endodontic
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ELJ
Class 1
Teeth, Artificial, Posterior With Metal Insert
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ELO
Class 1
Cusp, Gold And Stainless Steel
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EMO
Class 1
Knife, Periodontic
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EMP
Class 1
Marker, Periodontic
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EMQ
Class 1
Hoe, Periodontic
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JEO
Class 1
Measurer, Gingival Fluid
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KCS
Class 1
Pantograph
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KOK
Class 3
Sterilizer, Endodontic Dry Heat
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KON
Class 3
Adhesive, Denture, Polyacrylamide Polymer (Modified Cationic)
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KOR
Class 3
Adhesive, Denture, Karaya With Sodium Borate
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KOS
Class 3
Adhesive, Denture, Carboxymethylcellulose Sodium And Cationic Polyacrylamide Polymer
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KXW
Class 1
Adhesive, Denture, Carboxymethylcellulose Sodium (49%) And Ethylene-Oxide Homopolymer
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KXY
Class 3
Polyvinyl Methylether Maleic Anhydride &/Or Acid Copolymer & Carboxymethylce
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LZD
Class 3
Joint, Temporomandibular, Implant
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MMT
Class 3
Resin, Root Canal Filling Containing Chloroform
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MMU
Class 3
Adhesive, Denture, Acacia And Karaya With Sodium Borate > 12% By Weight
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MPI
Class 3
Glenoid Fossa Prosthesis
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MPJ
Class 3
Interarticular Disc Prosthesis (Interpositional Implant)
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MPL
Class 3
Mandibular Condyle Prosthesis
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MVH
Class 2
Device, Detection, Sulfide
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NFE
Class 2
Materials, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Alveolar Ridge Augmentation
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NFP
Class 2
Device, Dental Sonography, For Diagnosis Of Tmj / Mpd Disorders
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NFR
Class 2
Device, Jaw Tracking, For Diagnosis Of Tmj / Mpd Disorders
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NKJ
Class 1
Cushion, Pad, Denture, Wax Impregnated Cotton, Over The Counter
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NLC
Class 2
Bracket, Plastic, Orthodontic, Reprocessed
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NLD
Class 1
Instrument, Diamond, Dental, Reprocessed
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NME
Class 1
Bur, Diamond Coated, Reprocessed
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NMW
Class 1
Needle, Dental, Reprocessed
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NOB
Class 1
Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Non-Sterile
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NPZ
Class 3
Bone Grafting Material, Dental, With Biologic Component
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NQA
Class 3
Biologic Material, Dental
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NQS
Class 1
Bracket, Metal, Orthodontic, Reprocessed
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NRU
Class 1
Chair, Dental, Without Operative Unit
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NSB
Class 1
Patient Personal Hygiene Kit
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NUX
Class 1
Cleanser, Denture, Prescription
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NXZ
Class 1
Dental Hygiene Kit
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NYC
Class 1
Dental Prophylaxis Kit
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NYD
Class 2
Endodontic Kit
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NYE
Class 1
Fixture Mount Kit
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NYF
Class 1
Gingival Retraction Kit
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NYG
Class 1
Lapping Tool Kit
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OFW
Class 2
Restorative Instrument And Component Tray
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OFX
Class 1
General Purpose Dental Tray
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OFY
Class 1
Dental Implant Surgical Tray
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OGT
Class 1
Oral Irrigation Kit
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PWL
Class 1
Oral Surgery Tray
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QCJ
Class 2
Closed Loop Auto Titration Device For Oral Appliances
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QJJ
Class 1
Indirect Bonding Tray
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QJK
Class 2
Intraoral Camera
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QRQ
Class 1
Non-Irrigation Endosseous Dental Implant Drill Bits
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SBC
Class 2
Dental Image Analyzer
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SGQ
Class 2
Intraoral Phototherapy Device
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