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 |
| K241074 | Foshan SOCO Precision Instrument Co.,Ltd. | High-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19, SCHF22), Dental Low Speed Handpieces including Straight and Geared Angle Handpieces and Air Motors (Straight Handpieces: SCHD05-S, SCHD16-S, SCHD17-S, SCHD24-S, SCHD27-S Geared Angle Hand | 11/12/2024 |
| 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 |
| K240337 | Guangdong JINME Medical Technology Co., Ltd. | Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L) | 11/13/2024 |
| 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 |
| K233122 | Litu Tech Ltd. | High Speed Air Turbine Handpiece (G100,G200,G300,G400,G450,G500,G600,G700,G700L,G800,G800L) | 04/30/2024 |
| 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 |
| K233308 | NAKANISHI INC. | Air Motor (Model name: FX204 M4); Air Motor (Model name: M205) | 04/25/2024 |
| K241880 | NAKANISHI INC. | Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing System (Perio Mate Nozzle Tip) | 09/20/2024 |
| 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 |
| K242179 | W&H Dentalwerk Bⁿrmoos GmbH | Synea Fusion Handpieces (Intensiv & Profin) | 02/28/2025 |
| K162926 | W&H DENTALWERK BURMOOS GMBH | Air-Powered Handpieces and Handpiece Attachments | 02/23/2017 |
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