FDA 510(k) Applications for Medical Device Product Code "EFB"
(Handpiece, Air-Powered, Dental)

FDA 510(k) Number Applicant Device Name Decision Date
K073284 (EMS SA) ELECTRO MEDICAL SYSTEMS AIR-FLOW MASTER STANDARD 12/14/2007
K082716 A-DEC, INC. A-DEC/W&H ALEGRA AIR-DRIVEN HIGHSPEED HANDPIECE, MODEL TE-97, TE-98, A-DEC/W&H ALEGRA HANDPIECE ATTACHMENT, MODEL HE-43 01/15/2009
K082827 A-DEC, INC. A-DEC/W&H PROFIN RECIPROCATING CONTRA-ANGLE HANDPIECE ATTACHMENT 01/07/2009
K070663 A-DEC, INC. A-DEC/W&H SYNEA AIR-DRIVEN HIGHSPEED HANDPIECE, MODEL TA-98, TA-97, A-DEC/W&H SYNEA HANDPIECE ATTACHMENT 07/05/2007
K993526 A-DEC, INC. SYNEA - LS LOW-SPEED HANDPIECE 01/11/2000
K992011 A-DEC, INC. SYNEA-HS HIGH SPEED-HANDPIECE 09/10/1999
K010127 A-DEC, INC. W & H ASSISTINA 10/05/2001
K991401 ADVANCED TECHNOLOGY RESEARCH (A.T.R.) S.R.P. ATR 3000, ATR 2000, IMPLANT-PRO 12/15/1999
K000547 ADVANCED TECHNOLOGY RESEARCH (A.T.R.) S.R.P. ATR TECNIKA 05/03/2000
K101717 AEROBINE, INC DENTAL HANDPIECES, MODELS: KARAM STD/MINI; BREEZE STD/MINI: KARAM 45; DEXOR 45; KARAM 4H COUPLING 08/20/2010
K974670 ATHENA TECHNOLOGY, INC. ATHENA 1:1 CONTRA ANGLE, ATHENA 4:1 CONTRA ANGLE, ATHENA 16:1 CONTRA ANGLE, ATHENA 64:1 CONTRA ANGLE, ATHENA 16-: CONTRE 03/13/1998
K974671 ATHENA TECHNOLOGY, INC. ATHENA 20R S TYPE SLOW SPEED HANDPIECE MOTOR 03/11/1998
K072754 AXENIC DENTAL, INC. AXENIC DHP DISPOSABLE HIGH-PERFORMANCE HANDPIECE 01/25/2008
K172543 Beijing Dongbo Dental Handpiece Co., Ltd. High-speed Turbine Handpieces for Single Use 07/11/2018
K202371 Beijing Dongbo Dental Handpiece Co., Ltd. Highspeed Airturbine Handpiece 11/08/2021
K071561 BEIJING NORTH POLE DENTAL HANDPIECE CO., LTD HI-SPEED TURBINE HANDPIECES, MODEL GSO1-B,GSO2-B,GSO3-B,GSO1-D,GSO2-D 10/12/2007
K031851 BETHEL, INC DENTISEPTIC HPC 08/01/2003
K112623 BEYES DENTAL CANADA INC AIRLIGHT DENTAL HANDPIECE 12/16/2011
K112869 BEYES DENTAL CANADA INC EASYPROPHY SERIES AIR POLISH DEVICES, MODELS EASYPROPHY 200 AND EASYPROPHY 400 12/16/2011
K983183 BIEN AIR USA, INC. GYRO LONG-LIFE,BLACK PEARL ECO, ONDINE &CROMA, PRESTIGE, BORA, AQUILON, MC2,MC3, BASCH, ISOLITE, OPTIMA, US, PLPE, CA, P 12/10/1998
K984244 BIEN AIR USA, INC. ORL-E-92 SURGICAL DRILL SYSTEM 02/23/1999
K980585 BIOLASE TECHNOLOGY, INC. MILLENNIUM 10/08/1998
K000834 CASTELLINI S.P.A. CASTELLNI AIR POWERED HANDPIECES SYRINGES: THREE STERIL, MULTISTERIL TURBINS: CLEANAIR, CLEANLIGHT MICROMOTORS: IMPLANTO 12/14/2000
K033213 CODENT TECHNICAL INDUSTRY CO., LTD. CODENT DENTAL AIR-POWERED HANDPIECE, MODEL HPS 02/06/2004
K133069 CODENT TECHNICAL INDUSTRY CO., LTD. CODENT LOW SPEED DENTAL HANDPIECES AND ACCESSORIES 10/24/2014
K150798 CODENT TECHNICAL INDUSTRY CO., LTD. Codent Low Speed Dental Handpieces and Accessories 04/24/2015
K152146 CODENT TECHNICAL INDUSTRY CO., LTD. High Speed Handpieces and Accessories 12/08/2015
K981990 D.B.I. AMERICA CORP. MRS-400, MAXI 400, MRSL-400, MAXI 400L 06/22/1998
K101551 DELMA MEDICAL INSTRUMENT (GUANGZHOU) CO., LTD. PACEMAKER HIGH-SPEED HANDPIECE MODEL PM-MQ, PM-M 09/09/2010
K070297 DENTAL AIR SOLUTIONS OF NC, INC. CLEARVIEW DENTAL HANDPIECE LUBRICATOR AND LUBRICANT 02/05/2007
K960352 DENTAL DISPOSABLES INTL., INC. ALLRAP/SLIP-N-GRIP 02/21/1996
K160410 Dental Savings Club WOlf High Speed Handpieces - Medium head, WOlf High Speed Handpieces - Small head 09/29/2016
K982593 DENTALEZ GROUP LUBE FREE AUTOCHUCK TURBINE WITH VORTEX AIR SEAL FOR USE WITH STAR DENTAL 430 SERIES LUBE FREE HIGH SPEED DENTAL HANDPIE 10/22/1998
K130455 DENTALEZ GROUP, STARDENTAL DIVISION 430 SWL 45 AND 430 SW 45 HIGH-SPEED HANDPIECES 09/25/2013
K153411 DENTALEZ, INC. 430 Torque High-Speed Handpiece Series - 430 SWL Torque High Speed Handpiece, 430 SW Torque High Speed Handpiece 04/08/2016
K113301 DENTALEZ, INC. CONCENPIECE,HIGH-SPEED HANDPIECE SERIES 01/23/2012
K173465 DentalEZ, Inc. Concentrix MX-AC High-Speed Handpiece 03/28/2018
K070869 DENTALEZ, INC. PROPHY STAR 3 HYGIENE HANDPIECE, MODEL 264422 06/15/2007
K192412 DentalEZ, Inc. SD500 Elite LubeFree High Speed Handpiece, SD500 Elite Lubricated High Speed Handpiece, SD500 Pro LubeFree High Speed Handpiece, Pro Lubricated High Speed Handpiece 01/06/2020
K093072 DENTALEZ, INC. STARCARE HANDPIECE MAINTENANCE UNIT 12/28/2009
K053368 DENTSPLY INTERNATIONAL INTERPROXIMAL REDUCTION SYSTEM 03/29/2006
K041141 DENTSPLY INTL. DENTSPLY CAVITRON JET WAVE AIR POLISHING PROPHYLAXIS SYSTEM, MODEL G125 06/16/2004
K031145 DENTSPLY INTL. ESTYLUS ELECTRIC MOTOR SYSTEM 07/15/2003
K003518 DENTSPLY INTL. RAPIDD HIGHSPEED DENTAL HANDPIECE 01/09/2001
K012720 DENTSPLY INTL. TULSA CONTRA ANGLES 11/08/2001
K072989 DENTSPLY INTL., INC. AXIS SYSTEM 01/28/2008
K192409 Dentsply Sirona Midwest Rhino XE and Air Motor M 01/13/2020
K970104 DW INDUSTRIES, INC. SANI-SHIELD 05/06/1997
K132478 E.M.S. ELECTRO MEDICAL SYSTEMS S.A. AIR-FLOW HANDY 3.0 04/11/2014
K132480 E.M.S. ELECTRO MEDICAL SYSTEMS S.A. AIR-FLOW HANDY 3.0 PERIO 02/24/2014
K151912 E.M.S. ELECTRO MEDICAL SYSTEMS S.A. AIR-FLOW handy 3.0 PLUS 02/03/2016
K082791 E.M.S. ELECTRO MEDICAL SYSTEMS S.A. EMS AIR-FLOW MASTER 02/18/2009
K171174 E.M.S. Electro Medical Systems S.A. PERIO-FLOW nozzle 12/18/2017
K022119 ELECTRO MEDICAL SYSTEMS SA EMS AIR-FLOW HANDY 2 DENTAL HANDPIECE 07/25/2002
K991857 ELECTRO MEDICAL SYSTEMS, INC. AIRFLOW HANDY 10/07/1999
K092289 EMS ELECTRO MEDICAL SYSTEMS SA EMS AIR-FLOW HANDY PERIO 10/20/2009
K963664 FILMTECH, INC. DENTAL HANDPIECE AND ACCESSORY 10/24/1996
K181900 Foshan CICADA Dental Instrument Co., Ltd. Dental high speed handpiece, Dental low speed handpiece 12/09/2019
K220179 Foshan COXO Medical Instrument Co., Ltd. High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air Motors 09/22/2023
K181691 Foshan Wenjian Medical Instrument Co., Ltd. High-speed air turbine handpiece / Low-speed air turbine handpiece 05/26/2020
K972376 GLENWOOD, LLC. IMPACT AIR 45 HANDPIECE FOR PERIODONTAL USE 09/10/1997
K972375 GLENWOOD, LLC. IMPACT AIR 45 HANDPIECE FOR ENDODONTIC USE 09/10/1997
K170229 GUANGDONG JINME MEDICAL TECHNOLOGY CO., LTD. Dental High-speed Turbine Handpiece 11/08/2017
K170236 Guangdong JINME Medical Technology Co., Ltd. Dental Low-speed Turbine Handpiece 11/21/2017
K221548 Guilin Woodpecker Medical Instrument Co., Ltd. Dental Air Polishing Handpiece 09/28/2022
K142063 HANDPIECE CLUB, LLC #8C RENEGADE DENTAL HANDPIECE 10/28/2014
K100389 HANDPIECE HEADQUARTERS HHC PUSH-BUTTON REPLACEMENT TURBINE FOR MIDWEST TRADITION HANDPIECE MODEL MW TURBINE REPLACEMENT 08/12/2010
K143183 HANDPIECE HEADQUARTERS Maxima XTEND Handpiece Maintenance System 02/17/2015
K080682 HANDPIECE HEADQUARTERS INC. - HPR INC. HHC, SCORE, HENRY SCHEIN CANISTER HANDPIECE 09/11/2008
K113674 HANDPIECE HEADQUARTERS INC. - HPR INC. SPRAY & CLEAN HANDPIECE CLEANER& LUBRICANT MAXIMA HANDPIECE CLEANER & LUBRICANT EZCARE HANDPIECE CLEANER & LUBRICANT 04/05/2012
K100731 HARRY J. BOSWORTH CO. BOSWORTH AIR POLISHER 12/03/2010
K991492 HARRY J. BOSWORTH CO. LC COMPOSITE 12/02/1999
K043497 J. MORITA USA, INC. 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 03/21/2005
K091065 J. MORITA USA, INC. AIR TORX, MODEL TRA-200, TRA-200-CP3, TRA-200-CP4 10/16/2009
K190509 J. Morita USA, Inc. Lubrina 2 03/04/2020
K070074 J. MORITA USA, INC. LUBRINA, MODEL HIM-1 05/31/2007
K043498 J. MORITA USA, INC. TWIN POWER TURBINE HIGH SPEED AIR TURBINE DENTAL HANDPIECE 02/16/2005
K041755 J.R. MEDICAL TECHNOLOGIES, INC. CROMAX HIGH SPEED TURBINE HANDPIECE 10/22/2004
K221814 Jaintek Co.,Ltd OK Handpiece 07/15/2022
K062740 JINDELL MEDICAL INSTRUMENTS CO., LTD. JINDELL HIGH SPPED AIR TURBINE HANDPIECE, MODELS SW, SP, SU, ETU, MU 11/02/2006
K130560 KALTENBACH & VOIGT GMBH MASTERTORQUE LUX 8900 L 09/27/2013
K181110 Kaltenbach & Voigt GmbH PROPHYflex 4 04/10/2019
K012308 KAVO AMERICA KAVO QUATTROCARE 06/26/2002
K973876 KAVO AMERICA PROPHYFLEX 2, MODEL 2012 12/19/1997
K031868 KAVO AMERICA PROPHYPEARLS 07/09/2003
K141576 KAVO DO BRASIL INDUSTRIA E COMERCIO LTDA Maxima PRO 45L 05/04/2015
K961163 LARES RESEARCH, INC. LARES RESEARCH AS-1 LOWSPEED HANDPIECE 04/23/1996
K141221 LARES RESEARCH, INC. LARES ULTRALITE PROSTYLE HIGH-SPEED DENTAL HANDPIECES, LARES EURO PROSTYLE HIGH-SPEED DENTAL HANDPIECES, LARES TURBO+ PR 10/28/2014
K963843 MICRO MOTORS, INC. ELECTRIC SURGICAL IRRIGATION SYSTEM - DUAL CONTROLLER UNIT 03/31/1997
K961076 MICRO-MEGA SOCIETE ANONYME MM 324 04/26/1996
K961275 MICRO-MEGA SOCIETE ANONYME SIRIUS 10, 10L, 40, 40L 01/17/1997
K961235 MICRO-MEGA SOCIETE ANONYME SIRIUS 180, 180L, 230, 230L 01/08/1997
K133170 MICRON CORP. QUICK JET M 03/28/2014
K173943 MicroP Technology (Taiwan), Inc. Dental High-speed Handpiece and Accessories 07/24/2018
K202786 MicroP Technology (Taiwan), Inc. Dental Low-speed Handpieces and Accessories 09/03/2021
K022535 MICROTECH MICROTECH PUSH BUTTON HANDPIECE, MODEL MHS-A100 10/22/2002
K962877 MIDWEST DENTAL PRODUCTS CORP. MIDWEST 300 SE 10/18/1996
K955655 MIDWEST DENTAL PRODUCTS CORP. MIDWEST ONE 03/05/1996
K963050 MIDWEST DENTAL PRODUCTS CORP. TRADITION P, PUSH BUTTON HANDPIECE 10/11/1996
K032234 MK-DENT GMBH MK-DENT HIGH SPEED DENTAL HANDPIECE, MODELS HS 4021K, 4011K, 4012K, AND HS 6021K, 6011K, 6012K 10/02/2003
K051872 MK-DENT GMBH MK-DENT LOW SPEED HANDPIECES AND ACCESSORIES INCLUDING SPARE PARTS, TUBINGS, AND LIGHT POWER SYSTEM, MODELS: LS2011 10/03/2005
K141886 MODERN KOREA CO., LTD. MDK HANDPIECES 05/13/2015
K945256 MTC INDUSTRIES AND RESEARCH, LTD. MTC 7707 HIGH SPEED AIR TURBINE 01/29/1996
K960541 MTI PRECISION PRODUCTS LYNX DPA DISPOSABLE PROPHY ANGLE 03/28/1996
K070001 MTI PRECISION PRODUCTS MASTER CLASSIC 5K LOW SPEED HANDPIECE, 20K LOW SPEED HANDPIECE, TM5 LOW SPEED HANDPIECE AND TM20 LOW SPEED HANDPIECE 02/02/2007
K113222 NAKAMURA DENTAL HANDPIECE MFG. CO., LTD. ND LOWSPEED AIRMOTOR,ND HIGHSPEED AIRTURBINE HANDPIECE 02/23/2012
K073652 NAKAMURA MAGNIFIER CO., LTD. ND LOW SPEED AIRMOTOR AND HANDPIECE, HIGHSPEED AIRTURBINE HANDPIECE, E-TYPE STRAIGHT NOSECONE AND CONTRA ANGLE 03/20/2008
K203791 NAKANISHI INC. Stainless Turbine 06/21/2022
K230888 Nakanishi Inc. Titanium Turbine 06/02/2023
K081811 NAKANISHI, INC. CARE3 PLUS 01/21/2009
K163483 NAKANISHI, INC. PANA SPRAY Plus 08/15/2017
K032395 NAKANISHI, INC. PROPHY-MATE 10/17/2003
K112673 NAKANISHI, INC. PROPHY-MATE NEO 02/07/2012
K113655 NAKANISHI, INC. TI-MAX X TURBINE 03/05/2012
K112024 NAKANISHI, INC. TI-MAX X450 06/20/2012
K193264 Ningbo HPDOVE Dental Instruments Co., Ltd. Disposable High Speed Air Turbine Handpiece 08/11/2020
K093971 NORTH WEST MEDICAL INSTRUMENT (GROUP) CO., LTD. DENTAL HANDPIECE 04/22/2010
K000710 NOUVAG AG MD 10, SEM, SM 12, CBM 05/11/2000
K954722 NOUVAG AG MICRO-DISPENSER 7000 & MICRODISPENSER 8000 01/16/1996
K981679 NOUVAG AG TCM 3000 AND TCM ENDO 02/09/1999
K131014 NSK AMERICA CORP. PANA SPRAY PLUS 08/12/2013
K052700 NSK AMERICA CORP. PANA-SPRAY 12/20/2005
K962542 NSK NAKANISHI, INC. AIR MOTOR HANDPIECE TN-102 09/24/1996
K962543 NSK NAKANISHI, INC. ALPHA AIR HANDPIECE, ULTRA-PUSH, AL-SU, AL-MU, AL-TU 09/11/1996
K980162 NSK NAKANISHI, INC. MACH-SIGMA HANDPIECE, ULTRAPUSH 06/05/1998
K991701 NSK NAKANISHI, INC. MACH-SIGMA HANDPIECE, ULTRAPUSH, MODELS MACH-SIGMA MU (MINI HEAD), MACH-SIGMA SU (STD. HEAD), MACH-SIGMA TU (TORQUE HD) 08/10/1999
K971774 NSK NAKANISHI, INC. NSK PUSH-BUTTON MIDWEST REPLACEMENT TURBINE:FOR QUIETAIR AND TRADITION 06/20/1997
K983168 ORA INNOVATIONS, INC. AVANT HIGH SPEED HANDPIECE, AVANT FIBER OPTIC HIGH SPEED HANDPIECE, MODEL #'S AVANT HS 100 & AVANT HS 200 11/18/1998
K000847 ORASYSTEMS ORALUBE 09/27/2000
K000848 ORASYSTEMS TDK HANDPIECES 10/05/2000
K111249 ORTHOMATICS, INC. ORTHOSLENDERIZER 02/08/2012
K070155 OSSEO SCIENTIFIC, LLC INTEGRITY LOW SPEED DENTAL AIR HANDPIECE AND ATTACHMENT, MODELS: MOTOR INT-E, MOTOR INT-D AND ATTACHMENT INT-SNC 01/25/2007
K100833 OSSPRAY LTD SYLE SMARTIP 06/03/2010
K202674 Pac-Dent, Inc. Medidenta High Speed Handpieces 12/12/2022
K952927 PALISADES PHARMACEUTICS, INC. IMPACT AIR 45 4-HOLE 08/06/1996
K120218 PALM BEACH DENTAL SUPPLY D/B/A TEK USA TEK USA E-GENERATOR INTEGRATED LED HANDPIECE (HIGH & LOW SPEED AIR TURBNINE DENTAL HANDPIECE) 06/29/2012
K982050 PARKELL, INC. MODEL MS-2 HANDPIECE 09/02/1998
K971732 PAULINE M. NICHOLLS DENTAL HANDPIECE 01/11/2000
K062947 PENG LIM ENTERPRISE CO., LTD. HIGH SPEED AIR TURBINE HANDPIECE, MODELS SUPER-AIR AND SUPER-QD SERIES 12/14/2006
K954991 PHASE CHANGE PHASE CHANGE DENTAL LUBRICANT 01/04/1996
K170261 PREMIUM PLUS INTERNATIONAL LIMITED Premium Plus Prophy Air Motor 10/19/2017
K073353 PRODRIVE SYSTEMS, INC. DO-ALL DENTAL HANDPIECE LUBRICANT 12/07/2007
K090369 PRODRIVE SYSTEMS, INC. PRODRIVE LINE OF DENTAL HANDPIECES 02/27/2009
K062219 PRODRIVE SYSTEMS, INC. PRODRIVE SYSTEMS REPLACEMENT TURBINE 08/04/2006
K981869 PROFESSIONAL DENTAL MFG., INC. PRO-FLEX DISPOSABLE PROPHY ANGLE 08/11/1998
K080240 PROMIDENT LLC CHALLENGER/CLASSIC PUSH BUTTON HANDPIECE 02/07/2008
K092933 REDENT-NOVA LTD. SAF (SELF ADJUSTING FILE) 01/14/2010
K093084 ROLENCE ENT. INC. ROLENCE DENTAL HIGH SPEED HANDPIECE, RHP 12/16/2009
K072554 SABLE INDUSTRIES, INC. ACCESS AND ROTAMAX FIBER OPTIC HIGH SPEED DENTAL HANDPIECES 11/14/2007
K083101 SABLE INDUSTRIES, INC. PREMIUM SLOW SPEED; 20K AIR MOTOR, HEADS, CONTRA-ANGLES, STRAIGHT NOSECONES 02/23/2009
K221741 Saeshin Precision Co., Ltd. TRAUS Air Dental Handpiece 02/22/2023
K110379 SATELEC AIR-N-GO 12/08/2011
K071965 SATELEC I-SURGE 09/10/2007
K042787 SATELEC IS 40 MICROMOTOR 12/17/2004
K000049 SATELEC SUNI MAX 04/04/2000
K062418 SCICAN K-SPRAY, MODEL 085-2715 10/19/2006
K071891 SCICAN LTD. STATIS DENTAL HANDPIECES 09/13/2007
K073319 SCICAN LTD. STATMATIC 31 HANDPIECE MAINTENANCE UNIT 02/04/2008
K063110 SHANGHAI DENTAL INSTRUMENT FACTORY CST61 HIGH SPEED TURBINE HANDPIECE 10/26/2006
K212910 Shenzhen Carejoy Technology Co., Ltd. Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece 11/17/2022
K972436 SIEMENS AG T1 LINE DENTAL HANDPIECES 09/22/1997
K033812 SIRONA DENTAL SYSTEMS GMBH SIROAIR L AIR SCALER 02/23/2004
K131319 SIRONA DENTAL SYSTEMS GMBH T1/T2/T3 TURBINE FAMILY 05/30/2014
K955654 SPINTECH, INC. SHORTSTOP DISPOSABLE PROPHY ANGLE 02/08/1996
K093341 SYBRON DENTAL SPECIALTIES, INC. CENTURY MODEL 105C 04/05/2010
K073478 SYBRON DENTAL SPECIALTIES, INC. SUPERTORQUE HIGH-SPEED HANDPIECES AND GENTLEPOWER HANDPIECES AND ATTACHEMENTS 09/03/2008
K052822 THUNDER TIGER CORP. DENTAL AIR-POWERED HANDPIECE, MODELS TIGER 100, 101, 200, 201 AND 202 01/20/2006
K062812 THUNDER TIGER CORP. DENTAL AIR-POWERED HANDPIECE, MODELS TIGER 300T, 300K, 300W, 300B AND 300N 11/28/2006
K102517 THUNDER TIGER CORP. TIGER 500 SERIES HIGH SPEED HANDPIECES AND ATTACHMENTS 04/27/2011
K190508 TTBIO CORP. EVO 450 series High Speed Handpieces 12/11/2019
K141183 TTBIO CORP. EVO 500 SERIES HIGH SPEED HANDPIECES/TIGER 500/300/101 SERIES HIGH SPEED HANDPIECES 02/27/2015
K232243 Ttbio Corp. EVO 700 series high speed handpiece 08/23/2023
K992380 ULTRADENT PRODUCTS, INC. ENDO-EZE MOTOR AND HANDPIECE 10/13/1999
K143704 W & H Dentalwerk Buermoos GmbH Advanced Air System 11/23/2015
K090548 W & H DENTALWERK BUERMOOS GMBH CONTRA-ANGLE HANDPIECE KOMET OS30 06/30/2009
K171553 W & H Dentalwerk Buermoos GmbH W&H Assistina Twin 12/08/2017
K162926 W&H DENTALWERK BURMOOS GMBH Air-Powered Handpieces and Handpiece Attachments 02/23/2017


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