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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 1994-02-01

AIR COMPRESSOR, MODEL PAC 6.7

Applicant Defiance Electronics, Inc.

K number K934815

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EIA 1994-01-21

QUICK-CONNECT 360 SWIVEL TIP AUTOCLAVABLE SYRINGE

Applicant Dentalez Group

K number K931093

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EIA 1994-01-10

ACE BASIC DENTAL IMPLANT PACK I

Applicant Ace Surgical Supply Co., Inc.

K number K922652

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EIA 1994-01-10

ACE DENTAL IMPLANT KIT

Applicant Ace Surgical Supply Co., Inc.

K number K922651

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EIA 1994-01-10

ACE DENTAL IMPLANT CUSTOM SURGICAL PACK

Applicant Ace Surgical Supply Co., Inc.

K number K922650

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EIA 1994-01-10

ACE BASIC DENTAL IMPLANT PACK II

Applicant Ace Surgical Supply Co., Inc.

K number K922649

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EIA 1994-01-06

PRECISION INTRA-ORAL SCOPES

Applicant Precise Optics

K number K932878

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EIA 1994-01-06

A-DEC 2545 DUO IC MICRO-CART

Applicant A-Dec, Inc.

K number K925798

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EIA 1994-01-06

A-DEC 2544 DOCTORS IC MICRO-CART

Applicant A-Dec, Inc.

K number K925797

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EIA 1993-10-20

A-DEC 2611 ASSISTANT'S CART

Applicant A-Dec, Inc.

K number K933166

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EIA 1993-10-13

A-DEC 2912 DUO CART

Applicant A-Dec, Inc.

K number K933167

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EIA 1993-10-12

A-DEC 3127 ASSISTANT'S WALLMOUNT

Applicant A-Dec, Inc.

K number K933168

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EIA 1993-10-12

A-DEC 3131 DUO WALLMOUNT (WITH INSTRUMENTATION)

Applicant A-Dec, Inc.

K number K933165

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EIA 1993-10-12

A-DEC 2612 ASSISTANT'S CART

Applicant A-Dec, Inc.

K number K933163

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EIA 1993-10-05

PORT OPII, PORT OPIII

Applicant Mobile Dental Equipment Corp.

K number K923354

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EIA 1993-09-28

EVACUATOR, ORAL CAVITY

Applicant Den-Tal-Ez Mfg Co., Inc.

K number K932824

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EIA 1993-09-10

PRO-SCOPE MODEL # PS-4000

Applicant Pro-Den Systems, Inc.

K number K922942

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EIA 1993-08-24

MEDCAM

Applicant Medcam USA, Inc.

K number K925967

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EIA 1993-07-08

AS3000 OPERATIVE DENTAL UNIT (DELIVERY SYSTEM)

Applicant Den-Tal-Ez Mfg Co., Inc.

K number K931204

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EIA 1993-05-27

CLEAN UP

Applicant Bio-Probe, Inc.

K number K922985

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EIA 1993-02-12

WAGGONER DENTAL MANUFACTURING STERIWATER SYSTEM

Applicant Waggoner Dental Mfg.

K number K925829

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EIA 1992-05-04

AIR MEDICA III

Applicant Hinatawada Seimitsu Mfg. Co., Ltd.

K number K920710

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EIA 1991-12-27

MATRX MEDICAL MAXIMIZER 1000 AND 2000 VACUUM PUMP

Applicant Matrix Medica, Inc.

K number K915353

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EIA 1991-11-13

MDT/CASTLE PURUS DENTAL UNIT

Applicant Mdt Corp., Inc.

K number K914697

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EIA 1991-11-13

STOMAVISION (STV)

Applicant Trophy Radiologie

K number K913464

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EIA 1991-07-03

ORALCAM

Applicant Charmac Group, Inc.

K number K911594

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EIA 1991-06-24

MODEL 2100 PORTABLE FIELD UNIT

Applicant Dntl Corp.

K number K911506

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EIA 1991-02-20

ASEPTIMINI UNIT, ADU-10

Applicant Aseptico, Inc.

K number K905401

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EIA 1991-01-31

ORAL PHARYNGEAL CLEANSING DEVICE

Applicant Concord/Portex

K number K905011

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EIA 1991-01-30

PM2002 CC AND PM2002 EC

Applicant Planmeca USA, Inc.

K number K904948

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EIA 1990-10-24

A-DEC DECADE CUSPIDOR

Applicant A-Dec, Inc.

K number K903455

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EIA 1990-10-24

A-DEC IC MICRO-CART

Applicant A-Dec, Inc.

K number K903453

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EIA 1990-10-24

A-DEC IC CONTROL HEAD

Applicant A-Dec, Inc.

K number K903452

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EIA 1990-10-24

A-DEC PAC I PORTABLE UNIT

Applicant A-Dec, Inc.

K number K903451

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EIA 1990-08-15

SUCTION ORA-SWAB(R) BRUSH KIT

Applicant Sage Products, Inc.

K number K901806

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EIA 1990-07-06

RESUBMITTED WATER PURIFIER FOR USE W/DENTAL TREAT

Applicant Pelton & Crane Co.

K number K901672

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EIA 1990-02-12

DENTAL DELIVERY SYSTEM

Applicant Dentech Corp.

K number K896532

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EIA 1989-12-26

RAMCLEAN DENTAL VACUUM LINE CLEANER

Applicant Ramvac Corp.

K number K895877

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EIA 1989-12-26

RAMVAC DENTAL VACUUM SYSTEM

Applicant Ramvac Corp.

K number K895876

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EIA 1989-12-21

ISODENT

Applicant Eurodent, Inc.

K number K894058

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EIA 1989-11-21

STUDIO UNO

Applicant Eurodent, Inc.

K number K894061

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EIA 1989-10-13

ALLPAC(TM) MATERIAL

Applicant Barrier Concepts, Inc.

K number K894759

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EIA 1989-08-07

MATRX DENTAL UNIT

Applicant Matrix Medica, Inc.

K number K893219

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EIA 1989-05-24

QUICK-TIP (DENTAL OPERATORY UNIT)

Applicant Bernard S Esrock

K number K891006

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EIA 1989-03-17

BRACKET TABLE ARM COVER

Applicant Steri-Shield Products, Inc.

K number K884219

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EIA 1989-03-16

SANI-SLEEVE DRAPE FOR DENTAL USE

Applicant Nieusma R & D, Inc.

K number K885299

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EIA 1988-12-08

DELIVERY PUMP FOR STERILE IRRIGANT & HANDPIECE DR.

Applicant Aseptico, Inc.

K number K882526

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EIA 1988-12-07

APOLLO VS, VT, VR 1000/1500, FREEDOM HS, HT, HR

Applicant Apollo Dental Products, Inc.

K number K883904

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EIA 1988-10-14

PORTABLE II DENTAL DELIVERY SYSTEM

Applicant Dntl Corp.

K number K883775

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EIA 1988-08-12

EASY-OP, PORTABLE DENTAL CART

Applicant Wy'East Medical Corp.

K number K882810

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EIA 1986-10-17

DP32 HAND HELD DENTAL PROPHYLAXIS UNIT

Applicant Stewart J. Lustgarten

K number K861601

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EIA 1986-10-01

CM-II, CM-I WATER UNIT

Applicant Sds Dental, Inc.

K number K863021

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EIA 1986-09-26

EUROCART SR-4, EUROCART M-IV, ISOCART III

Applicant Sds Dental, Inc.

K number K863010

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EIA 1986-09-25

CABINET II AUXILIARY UNIT

Applicant Sds Dental, Inc.

K number K863023

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EIA 1986-03-14

SOLAR

Applicant Alpine Dental Equipment Co.

K number K854643

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EIA 1986-03-14

SOLAR CART

Applicant Alpine Dental Equipment Co.

K number K854642

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EIA 1986-03-10

SOLAR F

Applicant Alpine Dental Equipment Co.

K number K854641

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EIA 1985-10-24

FREEDOM LINE LUBRICATED MODELS LS-2-5, LT-6-10

Applicant Apollo Dental Products, Inc.

K number K852816

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EIA 1985-07-31

SATALEC SERVOTORQUE S2 SX2

Applicant Spelna, Inc.

K number K852524

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EIA 1985-07-31

TROPHY COMPACT - DENTAL UNIT

Applicant Trophy Radiologie

K number K851136

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EIA 1984-09-12

PM 2000 DENTAL UNIT

Applicant Planmeca USA, Inc.

K number K842357

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EIA 1983-10-19

SATELEC PROPHY UNIT PU-2000

Applicant Spelna, Inc.

K number K832673

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EIA 1982-12-03

STERILE WATER SYSTEM

Applicant Syntex Dental Products, Inc.

K number K823230

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EIA 1982-11-22

SA-21 DENTAL UNIT

Applicant Ritter Co.

K number K823180

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EIA 1982-11-17

AIR FLOW I

Applicant Healthco, Inc.

K number K823133

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EIA 1981-11-24

PORT-OP

Applicant Portec, Inc.

K number K813106

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EIA 1980-09-09

LITTLE GIANT I & II HANDPIECE CONTROL

Applicant Silverman'S

K number K801975

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EIA 1980-08-04

SPACELINE DENTAL CHAIR-UNIT

Applicant Pacific Dental Corp.

K number K801685

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EIA 1980-07-14

LARES AIR PRESSURE GAUGE

Applicant Lares Manufacturing Co., Inc.

K number K801534

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EIA 1980-03-17

ARISTOSURG 250

Applicant Halmon-Locren, Inc.

K number K800395

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EIA 1979-02-26

MOBILE UNITS, I,II,III,IV

Applicant Dentsply Intl.

K number K790112

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EIA 1978-12-28

MODULAT DENTAL SYSTEMS

Applicant Vacudent Sales Corp.

K number K781882

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EIA 1978-08-14

ULTRAMATE 990

Applicant Litton Dental Products

K number K781114

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EIA 1977-10-20

PERCEPTION SERIES DELIVERY SYS.

Applicant Chayes Virginia, Inc.

K number K771890

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EIA 1977-07-15

CB600, TURBINE CONTROL BOL

Applicant Litton Dental Products

K number K771252

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EIA 1977-07-15

HU:500, HYGIENASSIST

Applicant Litton Dental Products

K number K771251

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