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Unit, Operative Dental

FDA product code EIA · 276 cleared devices

Class 1 Dental

Regulation: 21 CFR 872.6640
Review panel: DE
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1977-07-15 – 2026-08-07

EIA 2000-05-03

3181 DUO DELIVERY SYSTEM

Applicant A-Dec, Inc.

K number K000968

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EIA 2000-05-03

4635 ASSISTANT'S INSTRUMENTATION

Applicant A-Dec, Inc.

K number K000967

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EIA 2000-05-03

4631 DUO DELIVERY SYSTEM

Applicant A-Dec, Inc.

K number K000966

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EIA 2000-04-13

ACUCAM CONCEPT IV, MODELS A1222B, A1223B, A1221B, A1121B, A1222C, A10402, A10403, A10401

Applicant Dentsply Intl.

K number K000112

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EIA 2000-04-06

STERLTECH WATER PURIFIER

Applicant Sterltech, Inc.

K number K000941

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EIA 1999-10-08

QUANTEC-E IRRIGATION SYSTEM 2

Applicant Sybron Dental Specialties, Inc.

K number K992195

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EIA 1999-09-08

DENTAPURE DP 90 CARTRIDGE, DENTAPURE DP 365 CARTRIDGE

Applicant Mrlb Intl., Inc.

K number K992893

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EIA 1999-09-07

DENTAPURE DP40 CARTRIDGE

Applicant Mrlb Intl., Inc.

K number K992868

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EIA 1999-09-03

ULTRA-KLEEN POWDER FOR DENTAL UNIT WATER LINES, MODELS 513P, 505L

Applicant Sterilex Corp.

K number K991946

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EIA 1999-06-30

DIFOTI SYSTEM

Applicant Electro-Optical Sciences, Inc.

K number K991098

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EIA 1999-06-24

QUANTEC-E IRRIGATION SYSTEM

Applicant Sybron Dental Specialties, Inc.

K number K991035

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EIA 1999-06-23

ORASCOPE

Applicant Fiberdent Corp.

K number K991011

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EIA 1999-05-28

STARDENTAL AXCS STERILE WATER SYSTEM

Applicant Dentalez Group

K number K990844

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EIA 1999-05-13

HYGENICLEAR WKR 1, WATER-DELIVERY DEVICE ULTRACLEAR

Applicant Hygenitek, Inc.

K number K990479

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EIA 1999-04-29

HYDRO-CAST ACRYLIC VARNISH, MODEL 78125

Applicant Kay See Dental Mfg. Co.

K number K991161

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EIA 1999-04-29

SPECTRA VU 1000 SERIES INTRAORAL CAMERA, SPECTRA VU 2000 SERIES INTRAORAL CAMERA, SPECTRA VU HDDI SV I INTRAORAL CAMERA,

Applicant International Technology Concepts

K number K984332

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EIA 1999-04-21

S575 INTRAORAL DOCKING DENTAL CAMERA

Applicant Sopro

K number K990948

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EIA 1999-03-29

FLEXISCOPE OPTOMODUL

Applicant Schoelly Fiberoptic GmbH

K number K984641

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EIA 1999-03-22

AIR TECHNIQUES' DENTO-VAC

Applicant Air Techniques, Inc.

K number K984584

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EIA 1999-02-09

ADEC DENTAL UNIT, MODELS CENTURY PLUS & CASCADE, DCI DENTAL UNIT, MODEL SERIES III

Applicant Lite Specialty Metal Works, Inc.

K number K984609

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EIA 1999-02-09

SCICAN CLASSIC

Applicant Scholly Fiberoptic GmbH

K number K984556

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EIA 1999-01-26

PLANMECA INTRACAM STATION

Applicant Planmeca Oy

K number K984013

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EIA 1999-01-19

OPTUM, INTRAORAL CAMERA SYSTEM

Applicant Camsight, Inc.

K number K983739

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EIA 1999-01-12

BELMONT UNIT, MODEL 6000 SERIES AND 7500 SERIES

Applicant Belmont Equipment Corp.

K number K983661

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EIA 1999-01-11

S555 INTRAORAL DENTAL CAMERA

Applicant Sopro

K number K983625

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EIA 1999-01-07

PALL DENTAL FILTRATION SYSTEM WITH AIR WATER SYRINGE HOUSING AND FILTER MEMBRANE

Applicant Pall Medical

K number K983735

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EIA 1998-12-21

PALL DENTAL FILTRATION SYSTEM WITH INLINE HANDPIECE HOUSING AND FILTER MEMBRANE

Applicant Pall Medical

K number K983731

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EIA 1998-12-11

SIRONA C8 DENTAL OPERATIVE UNIT WITH ACCESSORIES

Applicant Sirona Dental Systems GmbH

K number K983242

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EIA 1998-12-02

ERADIC-ALL

Applicant Theratechnologies, Inc.

K number K981171

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EIA 1998-12-01

MODIFICATION OF: ODYSSEY I DENTAL WATER UNIT

Applicant Germiphene Corp.

K number K983847

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EIA 1998-11-04

ENGLE DENTAL FAMILY OF DELIVERY SYSTEMS

Applicant Engle Dental Systems

K number K983285

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EIA 1998-11-04

BIO-2000

Applicant Micrylium Laboratories

K number K973765

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EIA 1998-10-15

KSEA ENDOSCOPES FOR DENTAL PROCEDURES

Applicant KARL STORZ Endoscopy-America, Inc.

K number K982658

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EIA 1998-10-15

BIOCLEAR CONCENTRATE

Applicant Waggoner Product Development

K number K981565

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EIA 1998-10-08

ULTRACAM

Applicant W. Edward Johansen

K number K973410

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EIA 1998-09-15

PERIOVIEW MODEL DV-1 FIBERSCOPE AND WINDOW SHEATH.

Applicant Dentalview, Inc.

K number K982480

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EIA 1998-09-15

CLEAN SOURCE I, MODEL CS1000

Applicant Aquarius Technologies, Inc.

K number K981144

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EIA 1998-09-04

FLUID CONTROL

Applicant T.A. Coleman Ent.

K number K982117

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EIA 1998-08-24

WELCH ALLYN REVEAL INTRAORAL CAMERA SYSTEM

Applicant Welch Allyn, Inc.

K number K981937

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EIA 1998-08-11

BONETRAP

Applicant Bladhs Plast AB

K number K980049

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EIA 1998-08-10

DIGITAL DOC

Applicant Digital Doc, LLC

K number K981663

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EIA 1998-08-03

THE PROMA PERCEPTION, RESPONSE AND COMPASS SYSTEM AND ACCESSORIES

Applicant Proma, Inc.

K number K980106

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EIA 1998-07-23

VIPERCAM

Applicant Integra Medical

K number K981534

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EIA 1998-06-25

ONE WEEK BACKSTOP DENTAL ANTI-RETRACTION CHECK VALVE

Applicant Scitech Solutions, Inc.

K number K982009

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EIA 1998-05-08

PRINCESS SYRINGE

Applicant Sodexco

K number K980577

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EIA 1998-04-13

TELICAM

Applicant Dental/Medical Diagnostic Systems, Inc.

K number K980474

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EIA 1998-02-18

SEAC ADVANCED DENTAL SYSTEM - MODEL 2001,2010 OR MODEL 2020

Applicant Asi Medical, Inc.

K number K974487

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EIA 1998-02-17

TRUE VISION, TRUE VISION II

Applicant Medical Dynamics, Inc.

K number K974542

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EIA 1998-02-04

DENTAL TRAY, STERILE, DISPOSABLE

Applicant Trinity Laboratories, Inc.

K number K974238

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EIA 1998-02-04

CLEARLINE PLUS, DENTAL WATERLINE FILTER

Applicant Scitech Solutions, Inc.

K number K973996

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EIA 1998-01-08

VISTACAM OMNI AND VIASTCAM OMNI (IC)

Applicant Air Techniques, Inc.

K number K974204

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EIA 1997-12-19

IGN 500 TM WATER CLEANING UNIT WITH CALBENIUM LIQUID

Applicant Airel-West

K number K964271

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EIA 1997-10-21

DENTALVIEW PERIOVIEW SYSTEM

Applicant Dentalview, Inc.

K number K973492

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EIA 1997-09-24

VIOLA II DENTAL CAMERA SYSTEM

Applicant Innovative Medical Systems, Inc.

K number K973035

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EIA 1997-09-12

DCI WATER PURIFIER

Applicant Dental Components, Inc.

K number K971727

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EIA 1997-07-03

PEFECT SHOT

Applicant International Imaging Electronics

K number K972019

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EIA 1997-07-03

PURE COMPANY FLUID DELIVERY SYSTEM

Applicant Pure Co.

K number K971278

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EIA 1997-06-20

PLANMECA INTRACAM

Applicant Planmeca Oy

K number K972033

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EIA 1997-06-19

INFECTION CONTROL CARTRIDGE

Applicant Dentalpure Corp.

K number K964942

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EIA 1997-05-23

ATRION MEDICAL AUTOGENOUS TISSUE COLLECTOR

Applicant Atrion Medical Products, Inc.

K number K971100

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EIA 1997-05-14

ODYSSEY I DENTAL WATER UNIT

Applicant Germiphene Corp.

K number K964796

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EIA 1997-04-04

EASY CAM

Applicant I.C.S.

K number K970626

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EIA 1997-03-05

STERILE WATER PUMP

Applicant Micro Motors, Inc.

K number K970002

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EIA 1997-01-22

DELIVERY SYSTEM(SDS 1400 XL)/DELIVERY SYSTEM CUSPIDOR(SDS1450,SDS1650 XL)

Applicant Sds Dental, Inc.

K number K964619

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EIA 1997-01-22

DENTAPURE DENTAL UNIT WATER LINE FILTER-IODINATED

Applicant Mrlb Intl., Inc.

K number K963548

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EIA 1996-11-22

CDR-CAM

Applicant Schick Technologies, Inc.

K number K963778

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EIA 1996-09-10

PROSTYLE COMPACT

Applicant Planmeca Oy

K number K961420

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EIA 1996-08-22

A-DEC SELF-CONTAINED WATER SYSTEM

Applicant A-Dec, Inc.

K number K962665

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EIA 1996-08-06

SPIRIT S1/S2

Applicant Pelton & Crane Co.

K number K962071

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EIA 1996-08-01

GENERAL PURPOSE DENTAL TRAY

Applicant Medcare Medical Group, Inc.

K number K962527

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EIA 1996-06-12

PORTA'PURE/DENTAL

Applicant Water Solution Technologies

K number K961409

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EIA 1996-05-08

BACSTOP DENTAL ANTI-RETRACTION CHECK VALVE

Applicant Scitech Solutions, Inc.

K number K960556

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EIA 1996-04-15

POWERS ANTI-BACTERIAL VALVE

Applicant Powers Dental & Medical Technology, Inc.

K number K954471

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EIA 1996-03-25

A-DEC PERFORMER CONTROL UNIT

Applicant A-Dec, Inc.

K number K960506

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EIA 1995-11-15

JACOBYSCOPE

Applicant Perioview, Inc.

K number K953912

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EIA 1995-09-19

STOMAVISION (STV)

Applicant Trophy Radiologie

K number K951074

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EIA 1995-05-23

SAFE-TIPS EZ

Applicant Safe Wave Products, Inc.

K number K951238

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EIA 1995-05-10

INTRAORAL VIDEO SCOPE AND WINDOW TUBE

Applicant Cuda Products Co.

K number K951019

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EIA 1995-04-18

THE AQUA-AIR PROFESSIONAL FIELD UNIT(S)

Applicant Aqua-Air Medical Devices, Inc.

K number K950175

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EIA 1995-03-17

VACSTAR

Applicant Air Techniques, Inc.

K number K942698

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EIA 1995-03-16

VISTACAM

Applicant Air Techniques, Inc.

K number K943204

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EIA 1995-03-01

SPIRIT II AND SPIRIT TREATMENT CENTER

Applicant Pelton & Crane Co.

K number K946187

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EIA 1994-12-29

DENTAL OPERATIVE UNIT ACCESORIES

Applicant Dci Intl.

K number K944271

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EIA 1994-11-22

OKTAS INTRA-ORAL DENTAL CAMERA

Applicant Oktas

K number K944256

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EIA 1994-09-09

E-VAC-U-ACCESSORIES

Applicant Bull Frog Mfg. Co.

K number K942520

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EIA 1994-09-02

MODEL 2600 PROCART

Applicant Compressor Technologies, Ltd.

K number K941476

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EIA 1994-08-10

MICRODONTIC LENS

Applicant New Image Industries, Inc.

K number K941716

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EIA 1994-08-02

DENTIST WITH ASSISTANT PACK

Applicant Sterile Concepts, Inc.

K number K940864

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EIA 1994-07-26

DENTAL TRAY

Applicant Cush Medical Products

K number K941349

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EIA 1994-07-13

METASYS AMALGAM SEPARATOR MST1

Applicant Metasys Dental Products, Inc.

K number K934500

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EIA 1994-07-12

A-DEC RADIUS 2122/2132

Applicant A-Dec, Inc.

K number K940893

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EIA 1994-06-10

ULTRACAM II

Applicant Dental Vision Direct, Inc.

K number K941452

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EIA 1994-06-02

SBP DENTAL UNIT

Applicant Northland Dental Engineering

K number K934436

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EIA 1994-05-16

KAVO INTRASEPT 905

Applicant Kavo America

K number K934783

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EIA 1994-04-29

DUAL AIR/WATER FILTER CARTRIDGE HANDLE KIT

Applicant Q. C. Filter, Inc.

K number K940599

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EIA 1994-04-21

A-DEC CASCADE 3072 WALLMOUNT

Applicant A-Dec, Inc.

K number K935325

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EIA 1994-03-31

ULTRACAM

Applicant Dental Vision Direct, Inc.

K number K933671

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EIA 1994-03-07

SEAC MOBILE UNIT BY ASI MEDICAL

Applicant Asi Medical, Inc.

K number K932873

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EIA 1994-02-22

THE SCITECH ONE-DAY FILTER

Applicant Scitech Solutions, Inc.

K number K930144

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EIA 1994-02-04

PERIO/ENDO LENS

Applicant New Image Industries, Inc.

K number K934002

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