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Handpiece, Air-Powered, Dental

FDA product code EFB · 248 cleared devices

Class 1 Dental

Regulation: 21 CFR 872.4200
Review panel: DE
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1976-08-11 – 2026-09-23

EFB 2006-03-29

INTERPROXIMAL REDUCTION SYSTEM

Applicant Dentsply International

K number K053368

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EFB 2006-01-20

DENTAL AIR-POWERED HANDPIECE, MODELS TIGER 100, 101, 200, 201 AND 202

Applicant Thunder Tiger Corp.

K number K052822

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EFB 2005-12-20

PANA-SPRAY

Applicant Nsk America Corp.

K number K052700

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EFB 2005-10-03

MK-DENT LOW SPEED HANDPIECES AND ACCESSORIES INCLUDING SPARE PARTS, TUBINGS, AND LIGHT POWER SYSTEM, MODELS: LS2011

Applicant Mk-Dent GmbH

K number K051872

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EFB 2005-03-21

AIR SOLFY, MODELS AS-4H, AS-4H-O, AS-4H-V, AS-4H-OV, AS-1,AS-1-0,AS-1-V, AS-1-OV

Applicant J. Morita USA, Inc.

K number K043497

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EFB 2005-02-16

TWIN POWER TURBINE HIGH SPEED AIR TURBINE DENTAL HANDPIECE

Applicant J. Morita USA, Inc.

K number K043498

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EFB 2004-12-17

IS 40 MICROMOTOR

Applicant Satelec

K number K042787

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EFB 2004-10-22

CROMAX HIGH SPEED TURBINE HANDPIECE

Applicant J.R. Medical Technologies, Inc.

K number K041755

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EFB 2004-06-16

DENTSPLY CAVITRON JET WAVE AIR POLISHING PROPHYLAXIS SYSTEM, MODEL G125

Applicant Dentsply Intl.

K number K041141

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EFB 2004-02-23

SIROAIR L AIR SCALER

Applicant Sirona Dental Systems GmbH

K number K033812

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EFB 2004-02-06

CODENT DENTAL AIR-POWERED HANDPIECE, MODEL HPS

Applicant Codent Technical Industry Co., Ltd.

K number K033213

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EFB 2003-10-17

PROPHY-MATE

Applicant Nakanishi, Inc.

K number K032395

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EFB 2003-10-02

MK-DENT HIGH SPEED DENTAL HANDPIECE, MODELS HS 4021K, 4011K, 4012K, AND HS 6021K, 6011K, 6012K

Applicant Mk-Dent GmbH

K number K032234

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EFB 2003-08-01

DENTISEPTIC HPC

Applicant Bethel, Inc.

K number K031851

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EFB 2003-07-15

ESTYLUS ELECTRIC MOTOR SYSTEM

Applicant Dentsply Intl.

K number K031145

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EFB 2003-07-09

PROPHYPEARLS

Applicant Kavo America

K number K031868

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EFB 2002-10-22

MICROTECH PUSH BUTTON HANDPIECE, MODEL MHS-A100

Applicant Microtech

K number K022535

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EFB 2002-07-25

EMS AIR-FLOW HANDY 2 DENTAL HANDPIECE

Applicant Electro Medical Systems SA

K number K022119

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EFB 2002-06-26

KAVO QUATTROCARE

Applicant Kavo America

K number K012308

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EFB 2001-11-08

TULSA CONTRA ANGLES

Applicant Dentsply Intl.

K number K012720

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EFB 2001-10-05

W & H ASSISTINA

Applicant A-Dec, Inc.

K number K010127

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EFB 2001-01-09

RAPIDD HIGHSPEED DENTAL HANDPIECE

Applicant Dentsply Intl.

K number K003518

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EFB 2000-12-14

CASTELLNI AIR POWERED HANDPIECES SYRINGES: THREE STERIL, MULTISTERIL TURBINS: CLEANAIR, CLEANLIGHT MICROMOTORS: IMPLANTO

Applicant Castellini S.P.A.

K number K000834

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EFB 2000-10-05

TDK HANDPIECES

Applicant Orasystems

K number K000848

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EFB 2000-09-27

ORALUBE

Applicant Orasystems

K number K000847

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EFB 2000-05-11

MD 10, SEM, SM 12, CBM

Applicant NOUVAG AG

K number K000710

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EFB 2000-05-03

ATR TECNIKA

Applicant Advanced Technology Research (A.T.R.) S.R.P.

K number K000547

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EFB 2000-04-04

SUNI MAX

Applicant Satelec

K number K000049

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EFB 2000-01-11

SYNEA - LS LOW-SPEED HANDPIECE

Applicant A-Dec, Inc.

K number K993526

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EFB 2000-01-11

DENTAL HANDPIECE

Applicant Pauline M. Nicholls

K number K971732

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EFB 1999-12-15

ATR 3000, ATR 2000, IMPLANT-PRO

Applicant Advanced Technology Research (A.T.R.) S.R.P.

K number K991401

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EFB 1999-12-02

LC COMPOSITE

Applicant Harry J. Bosworth Co.

K number K991492

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EFB 1999-10-13

ENDO-EZE MOTOR AND HANDPIECE

Applicant Ultradent Products, Inc.

K number K992380

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EFB 1999-10-07

AIRFLOW HANDY

Applicant Electro Medical Systems, Inc.

K number K991857

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EFB 1999-09-10

SYNEA-HS HIGH SPEED-HANDPIECE

Applicant A-Dec, Inc.

K number K992011

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EFB 1999-08-10

MACH-SIGMA HANDPIECE, ULTRAPUSH, MODELS MACH-SIGMA MU (MINI HEAD), MACH-SIGMA SU (STD. HEAD), MACH-SIGMA TU (TORQUE HD)

Applicant Nsk Nakanishi, Inc.

K number K991701

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EFB 1999-02-23

ORL-E-92 SURGICAL DRILL SYSTEM

Applicant Bien Air USA, Inc.

K number K984244

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EFB 1999-02-09

TCM 3000 AND TCM ENDO

Applicant NOUVAG AG

K number K981679

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EFB 1998-12-10

GYRO LONG-LIFE,BLACK PEARL ECO, ONDINE &CROMA, PRESTIGE, BORA, AQUILON, MC2,MC3, BASCH, ISOLITE, OPTIMA, US, PLPE, CA, P

Applicant Bien Air USA, Inc.

K number K983183

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EFB 1998-11-18

AVANT HIGH SPEED HANDPIECE, AVANT FIBER OPTIC HIGH SPEED HANDPIECE, MODEL #'S AVANT HS 100 & AVANT HS 200

Applicant Ora Innovations, Inc.

K number K983168

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EFB 1998-10-22

LUBE FREE AUTOCHUCK TURBINE WITH VORTEX AIR SEAL FOR USE WITH STAR DENTAL 430 SERIES LUBE FREE HIGH SPEED DENTAL HANDPIE

Applicant Dentalez Group

K number K982593

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EFB 1998-10-08

MILLENNIUM

Applicant Biolase Technology, Inc.

K number K980585

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EFB 1998-09-02

MODEL MS-2 HANDPIECE

Applicant Parkell, Inc.

K number K982050

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EFB 1998-08-11

PRO-FLEX DISPOSABLE PROPHY ANGLE

Applicant Professional Dental Mfg., Inc.

K number K981869

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EFB 1998-06-22

MRS-400, MAXI 400, MRSL-400, MAXI 400L

Applicant D.B.I. America Corp.

K number K981990

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EFB 1998-06-05

MACH-SIGMA HANDPIECE, ULTRAPUSH

Applicant Nsk Nakanishi, Inc.

K number K980162

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EFB 1998-03-13

ATHENA 1:1 CONTRA ANGLE, ATHENA 4:1 CONTRA ANGLE, ATHENA 16:1 CONTRA ANGLE, ATHENA 64:1 CONTRA ANGLE, ATHENA 16-: CONTRE

Applicant Athena Technology, Inc.

K number K974670

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EFB 1998-03-11

ATHENA 20R S TYPE SLOW SPEED HANDPIECE MOTOR

Applicant Athena Technology, Inc.

K number K974671

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EFB 1997-12-19

PROPHYFLEX 2, MODEL 2012

Applicant Kavo America

K number K973876

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EFB 1997-09-22

T1 LINE DENTAL HANDPIECES

Applicant Siemens AG

K number K972436

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EFB 1997-09-10

IMPACT AIR 45 HANDPIECE FOR PERIODONTAL USE

Applicant Glenwood, LLC

K number K972376

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EFB 1997-09-10

IMPACT AIR 45 HANDPIECE FOR ENDODONTIC USE

Applicant Glenwood, LLC

K number K972375

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EFB 1997-06-20

NSK PUSH-BUTTON MIDWEST REPLACEMENT TURBINE:FOR QUIETAIR AND TRADITION

Applicant Nsk Nakanishi, Inc.

K number K971774

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EFB 1997-05-06

SANI-SHIELD

Applicant Dw Industries, Inc.

K number K970104

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EFB 1997-03-31

ELECTRIC SURGICAL IRRIGATION SYSTEM - DUAL CONTROLLER UNIT

Applicant Micro Motors, Inc.

K number K963843

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EFB 1997-01-17

SIRIUS 10, 10L, 40, 40L

Applicant Micro-Mega Societe Anonyme

K number K961275

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EFB 1997-01-08

SIRIUS 180, 180L, 230, 230L

Applicant Micro-Mega Societe Anonyme

K number K961235

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EFB 1996-10-24

DENTAL HANDPIECE AND ACCESSORY

Applicant Filmtech, Inc.

K number K963664

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EFB 1996-10-18

MIDWEST 300 SE

Applicant Midwest Dental Products Corp.

K number K962877

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EFB 1996-10-11

TRADITION P, PUSH BUTTON HANDPIECE

Applicant Midwest Dental Products Corp.

K number K963050

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EFB 1996-09-24

AIR MOTOR HANDPIECE TN-102

Applicant Nsk Nakanishi, Inc.

K number K962542

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EFB 1996-09-11

ALPHA AIR HANDPIECE, ULTRA-PUSH, AL-SU, AL-MU, AL-TU

Applicant Nsk Nakanishi, Inc.

K number K962543

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EFB 1996-08-06

IMPACT AIR 45 4-HOLE

Applicant Palisades Pharmaceutics, Inc.

K number K952927

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EFB 1996-04-26

MM 324

Applicant Micro-Mega Societe Anonyme

K number K961076

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EFB 1996-04-23

LARES RESEARCH AS-1 LOWSPEED HANDPIECE

Applicant Lares Research, Inc.

K number K961163

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EFB 1996-03-28

LYNX DPA DISPOSABLE PROPHY ANGLE

Applicant Mti Precision Products

K number K960541

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EFB 1996-03-05

MIDWEST ONE

Applicant Midwest Dental Products Corp.

K number K955655

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EFB 1996-02-21

ALLRAP/SLIP-N-GRIP

Applicant Dental Disposables Intl., Inc.

K number K960352

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EFB 1996-02-08

SHORTSTOP DISPOSABLE PROPHY ANGLE

Applicant Spintech, Inc.

K number K955654

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EFB 1996-01-29

MTC 7707 HIGH SPEED AIR TURBINE

Applicant Mtc Industries and Research, Ltd.

K number K945256

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EFB 1996-01-16

MICRO-DISPENSER 7000 & MICRODISPENSER 8000

Applicant NOUVAG AG

K number K954722

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EFB 1996-01-04

PHASE CHANGE DENTAL LUBRICANT

Applicant Phase Change

K number K954991

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EFB 1995-11-08

DISPOSABLE PROPHY HANDPIECE

Applicant Denticator Intl., Inc.

K number K954012

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EFB 1995-10-05

W&H ROTO QUICK COUPLINGS

Applicant A-Dec, Inc.

K number K945734

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EFB 1995-10-05

W&H 100 SERIES LOW SPEED

Applicant A-Dec, Inc.

K number K944719

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EFB 1995-10-05

W&H 900 INCOLIGHT LT HANDPIECE

Applicant A-Dec, Inc.

K number K944718

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EFB 1995-08-28

W&H MICRO AIR MOTOR LT25

Applicant A-Dec, Inc.

K number K944713

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EFB 1995-08-25

W&H CORSAIR SCALER

Applicant A-Dec, Inc.

K number K944714

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EFB 1995-08-25

W&H MICRO MOTOR E25 (WITHOUT LIGHT)

Applicant A-Dec, Inc.

K number K944712

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EFB 1995-08-25

W&H AIR MOTOR A25

Applicant A-Dec, Inc.

K number K944711

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EFB 1995-08-15

PROTECTORAL ULTRASONIC HANDPIECE PROCESSOR

Applicant Gull Laboratories, Inc.

K number K932333

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EFB 1995-06-08

W&H 896 TOP LIGH HIGHSPEED

Applicant A-Dec, Inc.

K number K944709

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EFB 1995-06-02

W&H 798 TOP AIR TURBINE TRIPLE SPRAY

Applicant A-Dec, Inc.

K number K944717

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EFB 1995-06-02

W&H 796 TOP AIR TURBINE MINI-HEAD

Applicant A-Dec, Inc.

K number K944716

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EFB 1995-06-02

W&H 795 TOP AIR TURBINE SINGLE SPRAY

Applicant A-Dec, Inc.

K number K944715

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EFB 1995-06-02

W&H 898 TOP LIGHT HIGHSPEED

Applicant A-Dec, Inc.

K number K944710

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EFB 1995-06-02

W&H 895 TOP LIGH HIGHSPEED FIBEROPTIC SINGLE SPRAY

Applicant A-Dec, Inc.

K number K944708

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EFB 1995-03-31

MICRO RSH HIGH SPEED HANDPIECE

Applicant Micro Motors, Inc.

K number K935676

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EFB 1995-03-21

DENTOOL

Applicant Dentool, Inc.

K number K923780

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EFB 1994-12-29

LYNX LOW-SPEED HANDPIECE

Applicant Mti Precision Products

K number K940261

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EFB 1994-12-15

ATHENA HIGH SPEED HANDPIECE

Applicant Athena Technology, Inc.

K number K925678

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EFB 1994-07-06

STERI-LUBE

Applicant Petroleum Products of America

K number K942672

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EFB 1994-03-04

CA AND ST

Applicant Dabi-Atlante America Corp.

K number K926155

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EFB 1994-03-04

HANDPIECE MODELS: MS-350;RS-350;N-270 AIR-MOTOR

Applicant Dabi-Atlante America Corp.

K number K926154

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EFB 1994-01-31

TEK-LUBE

Applicant Clinical Technology Corp.

K number K925080

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EFB 1993-09-29

ORAL-B DISPOSABLE PROPHY ANGLE W/PROPHY CUP

Applicant Oral-B Laboratories

K number K932990

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EFB 1993-07-22

HIGH SPEED DENTAL DRILL/HANDPIECE

Applicant Feather Touch, Inc.

K number K925739

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EFB 1993-07-22

STERI-SOL SOLUTION, MODIFICATION

Applicant Anodia Systems

K number K925378

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EFB 1993-03-31

OPTI-SHIELD

Applicant Fuji Optical Systems, Inc.

K number K924089

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EFB 1992-12-21

HANDPIECE MODELS MS-350, RS-350; AIR MOTOR N-270

Applicant Dabi-Atlante America Corp.

K number K922437

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