FDA Product Code
FDA Product Code EFB — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Dental
- 21 CFR Citation
- 872.4200
510(k) Clearances — 263 records · page 1 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260029 | Firstar Dental Handpieces | FDC Technology Industry Co. | 2026-10-01 | Traditional | PDF ↗ |
| K262144 | DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor Handpiece | SETAGAYA SEIKI Co., Ltd. | 2026-09-23 | Traditional | PDF ↗ |
| K251388 | Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES, TM-SG20, TM-X25, TM-BB, TM-IC, TM-RA41) | Foshan Topmed Dental Co., Ltd. | 2026-01-12 | Traditional | PDF ↗ |
| K251389 | High speed air turbine handpiece | Foshan Topmed Dental Co., Ltd. | 2026-01-12 | Traditional | PDF ↗ |
| K242179 | Synea Fusion Handpieces (Intensiv & Profin) | W&H Dentalwerk Bürmoos GmbH | 2025-02-28 | Traditional | PDF ↗ |
| K240337 | Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L) | Guangdong Jinme Medical Technology Co., Ltd. | 2024-11-13 | Traditional | PDF ↗ |
| K241074 | 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 Handpieces: SCHD05-C, SCHD06-C, SCHD16-C, SCHD17-C, SCHD24-C, SCHD27-C, SCHD29-S, SCHB4, SCHB5, SCHB20, SCHB64 Air Motors: SCHD16-M, SCHD17-M, SCHD24-M, SCHD27-M) | Foshan Soco Precision Instrument Co., Ltd. | 2024-11-12 | Traditional | PDF ↗ |
| K241880 | Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing System (Perio Mate Nozzle Tip) | Nakanishi, Inc. | 2024-09-20 | Traditional | PDF ↗ |
| K233122 | High Speed Air Turbine Handpiece (G100,G200,G300,G400,G450,G500,G600,G700,G700L,G800,G800L) | Litu Tech , Ltd. | 2024-04-30 | Traditional | PDF ↗ |
| K233308 | Air Motor (Model name: FX204 M4); Air Motor (Model name: M205) | Nakanishi, Inc. | 2024-04-25 | Traditional | PDF ↗ |
| K220179 | High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air Motors | Foshan Coxo Medical Instrument Co., Ltd. | 2023-09-22 | Traditional | PDF ↗ |
| K232243 | EVO 700 series high speed handpiece | Ttbio Corp. | 2023-08-23 | Special | PDF ↗ |
| K230888 | Titanium Turbine | Nakanishi, Inc. | 2023-06-02 | Traditional | PDF ↗ |
| K221741 | TRAUS Air Dental Handpiece | Saeshin Precision Co., Ltd. | 2023-02-22 | Traditional | PDF ↗ |
| K202674 | Medidenta High Speed Handpieces | Pac-Dent, Inc. | 2022-12-12 | Traditional | PDF ↗ |
| K212910 | Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece | Shenzhen Carejoy Technology Co., Ltd. | 2022-11-17 | Traditional | PDF ↗ |
| K221548 | Dental Air Polishing Handpiece | Guilin Woodpecker Medical Instrument Co., Ltd. | 2022-09-28 | Traditional | PDF ↗ |
| K221814 | OK Handpiece | Jaintek Co.,Ltd | 2022-07-15 | Traditional | PDF ↗ |
| K203791 | Stainless Turbine | Nakanishi, Inc. | 2022-06-21 | Traditional | PDF ↗ |
| K202371 | Highspeed Airturbine Handpiece | Beijing Dongbo Dental Handpiece Co., Ltd. | 2021-11-08 | Traditional | PDF ↗ |
| K202786 | Dental Low-speed Handpieces and Accessories | Microp Technology (Taiwan), Inc. | 2021-09-03 | Traditional | PDF ↗ |
| K193264 | Disposable High Speed Air Turbine Handpiece | Ningbo Hpdove Dental Instruments Co., Ltd. | 2020-08-11 | Traditional | PDF ↗ |
| K181691 | High-speed air turbine handpiece / Low-speed air turbine handpiece | Foshan Wenjian Medical Instrument Co., Ltd. | 2020-05-26 | Traditional | PDF ↗ |
| K190509 | Lubrina 2 | J. Morita USA, Inc. | 2020-03-04 | Traditional | PDF ↗ |
| K192409 | Midwest Rhino XE and Air Motor M | Dentsply Sirona | 2020-01-13 | Traditional | PDF ↗ |
| K192412 | SD500 Elite LubeFree High Speed Handpiece, SD500 Elite Lubricated High Speed Handpiece, SD500 Pro LubeFree High Speed Handpiece, Pro Lubricated High Speed Handpiece | Dentalez, Inc. | 2020-01-06 | Traditional | PDF ↗ |
| K190508 | EVO 450 series High Speed Handpieces | Ttbio Corp. | 2019-12-11 | Traditional | PDF ↗ |
| K181900 | Dental high speed handpiece, Dental low speed handpiece | Foshan Cicada Dental Instrument Co, Ltd. | 2019-12-09 | Traditional | PDF ↗ |
| K181110 | PROPHYflex 4 | Kaltenbach & Voigt GmbH | 2019-04-10 | Traditional | PDF ↗ |
| K173943 | Dental High-speed Handpiece and Accessories | Microp Technology (Taiwan), Inc. | 2018-07-24 | Traditional | PDF ↗ |
| K172543 | High-speed Turbine Handpieces for Single Use | Beijing Dongbo Dental Handpiece Co., Ltd. | 2018-07-11 | Traditional | PDF ↗ |
| K173465 | Concentrix MX-AC High-Speed Handpiece | Dentalez, Inc. | 2018-03-28 | Traditional | PDF ↗ |
| K171174 | PERIO-FLOW nozzle | E.M.S Electro Medical Systems S.A | 2017-12-18 | Traditional | PDF ↗ |
| K171553 | W&H Assistina Twin | W&H Dentalwerk Buermoos GmbH | 2017-12-08 | Traditional | PDF ↗ |
| K170236 | Dental Low-speed Turbine Handpiece | Guangdong Jinme Medical Technology Co., Ltd. | 2017-11-21 | Traditional | PDF ↗ |
| K170229 | Dental High-speed Turbine Handpiece | Guangdong Jinme Medical Technology Co., Ltd. | 2017-11-08 | Traditional | PDF ↗ |
| K170261 | Premium Plus Prophy Air Motor | Premium Plus International Limited | 2017-10-19 | Abbreviated | PDF ↗ |
| K163483 | PANA SPRAY Plus | Nakanishi, Inc. | 2017-08-15 | Traditional | PDF ↗ |
| K162926 | Air-Powered Handpieces and Handpiece Attachments | W&H Dentalwerk Burmoos GmbH | 2017-02-23 | Traditional | PDF ↗ |
| K160410 | WOlf High Speed Handpieces - Medium head, WOlf High Speed Handpieces - Small head | Dental Savings Club | 2016-09-29 | Traditional | PDF ↗ |
| K153411 | 430 Torque High-Speed Handpiece Series - 430 SWL Torque High Speed Handpiece, 430 SW Torque High Speed Handpiece | Dentalez, Inc. | 2016-04-08 | Traditional | PDF ↗ |
| K151912 | AIR-FLOW handy 3.0 PLUS | E.M.S Electro Medical Systems S.A | 2016-02-03 | Traditional | PDF ↗ |
| K152146 | High Speed Handpieces and Accessories | Codent Technical Industry Co., Ltd. | 2015-12-08 | Traditional | PDF ↗ |
| K143704 | Advanced Air System | W&H Dentalwerk Buermoos GmbH | 2015-11-23 | Traditional | PDF ↗ |
| K141886 | MDK HANDPIECES | Modern Korea Co., Ltd. | 2015-05-13 | Traditional | PDF ↗ |
| K141576 | Maxima PRO 45L | Kavo DO Brasil Industria E Comercio Ltda | 2015-05-04 | Traditional | PDF ↗ |
| K150798 | Codent Low Speed Dental Handpieces and Accessories | Codent Technical Industry Co., Ltd. | 2015-04-24 | Special | PDF ↗ |
| K141183 | EVO 500 SERIES HIGH SPEED HANDPIECES/TIGER 500/300/101 SERIES HIGH SPEED HANDPIECES | Ttbio Corp. | 2015-02-27 | Abbreviated | PDF ↗ |
| K143183 | Maxima XTEND Handpiece Maintenance System | Handpiece Headquarters | 2015-02-17 | Traditional | PDF ↗ |
| K141221 | LARES ULTRALITE PROSTYLE HIGH-SPEED DENTAL HANDPIECES, LARES EURO PROSTYLE HIGH-SPEED DENTAL HANDPIECES, LARES TURBO+ PR | Lares Research, Inc. | 2014-10-28 | Abbreviated | PDF ↗ |
| K142063 | #8C RENEGADE DENTAL HANDPIECE | Handpiece Club, LLC | 2014-10-28 | Traditional | PDF ↗ |
| K133069 | CODENT LOW SPEED DENTAL HANDPIECES AND ACCESSORIES | Codent Technical Industry Co., Ltd. | 2014-10-24 | Traditional | PDF ↗ |
| K131319 | T1/T2/T3 TURBINE FAMILY | Sirona Dental Systems GmbH | 2014-05-30 | Traditional | PDF ↗ |
| K132478 | AIR-FLOW HANDY 3.0 | E.M.S Electro Medical Systems S.A | 2014-04-11 | Traditional | PDF ↗ |
| K133170 | QUICK JET M | Micron Corp. | 2014-03-28 | Traditional | PDF ↗ |
| K132480 | AIR-FLOW HANDY 3.0 PERIO | E.M.S Electro Medical Systems S.A | 2014-02-24 | Traditional | PDF ↗ |
| K130560 | MASTERTORQUE LUX 8900 L | Kaltenbach & Voigt GmbH | 2013-09-27 | Traditional | PDF ↗ |
| K130455 | 430 SWL 45 AND 430 SW 45 HIGH-SPEED HANDPIECES | Dentalez Group, Stardental Division | 2013-09-25 | Traditional | PDF ↗ |
| K131014 | PANA SPRAY PLUS | Nsk America Corp. | 2013-08-12 | Traditional | PDF ↗ |
| K120218 | TEK USA E-GENERATOR INTEGRATED LED HANDPIECE (HIGH & LOW SPEED AIR TURBNINE DENTAL HANDPIECE) | Palm Beach Dental Supply D/B/A Tek USA | 2012-06-29 | Traditional | PDF ↗ |
| K112024 | TI-MAX X450 | Nakanishi, Inc. | 2012-06-20 | Traditional | PDF ↗ |
| K113674 | SPRAY & CLEAN HANDPIECE CLEANER& LUBRICANT MAXIMA HANDPIECE CLEANER & LUBRICANT EZCARE HANDPIECE CLEANER & LUBRICANT | Handpiece Headquarters, Inc. - Hpr, Inc. | 2012-04-05 | Traditional | PDF ↗ |
| K113655 | TI-MAX X TURBINE | Nakanishi, Inc. | 2012-03-05 | Traditional | PDF ↗ |
| K113222 | ND LOWSPEED AIRMOTOR,ND HIGHSPEED AIRTURBINE HANDPIECE | Nakamura Dental Handpiece Mfg. Co., Ltd. | 2012-02-23 | Traditional | PDF ↗ |
| K111249 | ORTHOSLENDERIZER | Orthomatics, Inc. | 2012-02-08 | Traditional | PDF ↗ |
| K112673 | PROPHY-MATE NEO | Nakanishi, Inc. | 2012-02-07 | Traditional | PDF ↗ |
| K113301 | CONCENPIECE,HIGH-SPEED HANDPIECE SERIES | Dentalez, Inc. | 2012-01-23 | Traditional | PDF ↗ |
| K112623 | AIRLIGHT DENTAL HANDPIECE | Beyes Dental Canada, Inc. | 2011-12-16 | Traditional | PDF ↗ |
| K112869 | EASYPROPHY SERIES AIR POLISH DEVICES, MODELS EASYPROPHY 200 AND EASYPROPHY 400 | Beyes Dental Canada, Inc. | 2011-12-16 | Traditional | PDF ↗ |
| K110379 | AIR-N-GO | Satelec | 2011-12-08 | Traditional | PDF ↗ |
| K102517 | TIGER 500 SERIES HIGH SPEED HANDPIECES AND ATTACHMENTS | Thunder Tiger Corp. | 2011-04-27 | Traditional | PDF ↗ |
| K100731 | BOSWORTH AIR POLISHER | Harry J. Bosworth Co. | 2010-12-03 | Traditional | PDF ↗ |
| K101551 | PACEMAKER HIGH-SPEED HANDPIECE MODEL PM-MQ, PM-M | Delma Medical Instrument (Guangzhou) Co., Ltd. | 2010-09-09 | Traditional | PDF ↗ |
| K101717 | DENTAL HANDPIECES, MODELS: KARAM STD/MINI; BREEZE STD/MINI: KARAM 45; DEXOR 45; KARAM 4H COUPLING | Aerobine, Inc. | 2010-08-20 | Traditional | PDF ↗ |
| K100389 | HHC PUSH-BUTTON REPLACEMENT TURBINE FOR MIDWEST TRADITION HANDPIECE MODEL MW TURBINE REPLACEMENT | Handpiece Headquarters | 2010-08-12 | Traditional | PDF ↗ |
| K100833 | SYLE SMARTIP | Osspray, Ltd. | 2010-06-03 | Traditional | PDF ↗ |
| K093971 | DENTAL HANDPIECE | North West Medical Instrument (Group) Co., Ltd. | 2010-04-22 | Traditional | PDF ↗ |
| K093341 | CENTURY MODEL 105C | Sybron Dental Specialties, Inc. | 2010-04-05 | Traditional | PDF ↗ |
| K092933 | SAF (SELF ADJUSTING FILE) | Redent-Nova , Ltd. | 2010-01-14 | Traditional | PDF ↗ |
| K093072 | STARCARE HANDPIECE MAINTENANCE UNIT | Dentalez, Inc. | 2009-12-28 | Traditional | PDF ↗ |
| K093084 | ROLENCE DENTAL HIGH SPEED HANDPIECE, RHP | Rolence Ent., Inc. | 2009-12-16 | Traditional | PDF ↗ |
| K092289 | EMS AIR-FLOW HANDY PERIO | E.M.S Electro Medical Systems S.A | 2009-10-20 | Traditional | PDF ↗ |
| K091065 | AIR TORX, MODEL TRA-200, TRA-200-CP3, TRA-200-CP4 | J. Morita USA, Inc. | 2009-10-16 | Traditional | PDF ↗ |
| K090548 | CONTRA-ANGLE HANDPIECE KOMET OS30 | W&H Dentalwerk Buermoos GmbH | 2009-06-30 | Abbreviated | PDF ↗ |
| K090369 | PRODRIVE LINE OF DENTAL HANDPIECES | Prodrive Systems, Inc. | 2009-02-27 | Traditional | PDF ↗ |
| K083101 | PREMIUM SLOW SPEED; 20K AIR MOTOR, HEADS, CONTRA-ANGLES, STRAIGHT NOSECONES | Sable Industries, Inc. | 2009-02-23 | Abbreviated | PDF ↗ |
| K082791 | EMS AIR-FLOW MASTER | E.M.S Electro Medical Systems S.A | 2009-02-18 | Traditional | PDF ↗ |
| K081811 | CARE3 PLUS | Nakanishi, Inc. | 2009-01-21 | Traditional | PDF ↗ |
| K082716 | A-DEC/W&H ALEGRA AIR-DRIVEN HIGHSPEED HANDPIECE, MODEL TE-97, TE-98, A-DEC/W&H ALEGRA HANDPIECE ATTACHMENT, MODEL HE-43 | A-Dec, Inc. | 2009-01-15 | Abbreviated | PDF ↗ |
| K082827 | A-DEC/W&H PROFIN RECIPROCATING CONTRA-ANGLE HANDPIECE ATTACHMENT | A-Dec, Inc. | 2009-01-07 | Abbreviated | PDF ↗ |
| K080682 | HHC, SCORE, HENRY SCHEIN CANISTER HANDPIECE | Handpiece Headquarters, Inc. - Hpr, Inc. | 2008-09-11 | Abbreviated | PDF ↗ |
| K073478 | SUPERTORQUE HIGH-SPEED HANDPIECES AND GENTLEPOWER HANDPIECES AND ATTACHEMENTS | Sybron Dental Specialties, Inc. | 2008-09-03 | Traditional | PDF ↗ |
| K073652 | ND LOW SPEED AIRMOTOR AND HANDPIECE, HIGHSPEED AIRTURBINE HANDPIECE, E-TYPE STRAIGHT NOSECONE AND CONTRA ANGLE | Nakamura Magnifier Co., Ltd. | 2008-03-20 | Traditional | PDF ↗ |
| K080240 | CHALLENGER/CLASSIC PUSH BUTTON HANDPIECE | Promident, LLC | 2008-02-07 | Traditional | PDF ↗ |
| K073319 | STATMATIC 31 HANDPIECE MAINTENANCE UNIT | Scican , Ltd. | 2008-02-04 | Traditional | PDF ↗ |
| K072989 | AXIS SYSTEM | Dentsply Intl., Inc. | 2008-01-28 | Traditional | PDF ↗ |
| K072754 | AXENIC DHP DISPOSABLE HIGH-PERFORMANCE HANDPIECE | Axenic Dental, Inc. | 2008-01-25 | Traditional | PDF ↗ |
| K073284 | AIR-FLOW MASTER STANDARD | (Ems Sa) Electro Medical Systems | 2007-12-14 | Special | PDF ↗ |
| K073353 | DO-ALL DENTAL HANDPIECE LUBRICANT | Prodrive Systems, Inc. | 2007-12-07 | Traditional | PDF ↗ |
| K072554 | ACCESS AND ROTAMAX FIBER OPTIC HIGH SPEED DENTAL HANDPIECES | Sable Industries, Inc. | 2007-11-14 | Abbreviated | PDF ↗ |
Product code EFB · Class I · Dental. Data: openFDA.