Surgical devices · 21 CFR 872 Subpart E
Dental Air-Powered Handpiece
FDA device type “Handpiece, Air-Powered, Dental”.
- Companies listing it
- 9054 makers
- Brands and models
- 1,126
- 510(k) clearances
- 26319 in five years
- FDA name
- Handpiece, Air-Powered, Dental
510(k) clearances per year, 1976–2026
Companies that list EFB
90 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Dentsply Sirona, Inc. | United States | Maker | Midwest E mini · Midwest Rhino XP · Midwest Shorty Single Speed Air Motor · Midwest Shorty Two Speed Air Motor · +1 | 148 | 2026 |
| Nakanishi, Inc. | Japan | Maker | A450L · AB450L SU · AIR MOTOR HANDPIECE TN-102 · AK400L · +226 | 37 | 2026 |
| Guilin Woodpecker Medical Instrument Co., Ltd. | China | Maker | AP-H · AP-H Plus · AP-Mini · AP-Mini+ · +2 | 12 | 2025 |
| Sybron Dental Specialties | United States | Maker | ALLRAP/SLIP-N-GRIP | 203 | 2026 |
| Foshan COXO Medical Instrument Co., Ltd. | China | Maker | Air Motors; CX235-3B, CX235-3C, CX235-3F · Geared Angle Handpieces; CX235-1B, CX235-1C, CX235-1F, CX235-1G, CX235C1, CX235C2, CX235C3 · Geared Angle Handpieces; CX235C4, CX235C5, CX235C6, CX235C7, CX235C8, CX235-2S, CX235-2S1 · High-Speed Air Turbine Handpieces; CX207-C, CX207-C-2, CX207-G, CX207-W, CX207-W-2 · +2 | 6 | 2025 |
| Inter-Med, Inc. | United States | Maker | Impact Air 45 | 7 | 2026 |
| Dent4You AG | Switzerland | Maker | STATCARE Handpiece Spray · STATMATIC Spray | 5 | 2026 |
| Young Innovations Inc | United States | Maker | Athena 20R E Type Motor · Athena Champion Reusable Prophy Angle · Athena High Speed Handpiece · contra angle handpiece attachment · +5 | 23 | 2025 |
| Saeshin Precision Co., Ltd. | South Korea | Maker | TRAUS high-speed air turbine Handpieces | 16 | 2026 |
| Guangdong JINME Medical Technology Co., Ltd. | China | Maker | Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L) · Dental High-Speed Turbine Handpiece (Model: T, S, TU, SU, TP, SP, TUQ, TUP, SUP, SUQ, TUQP, SUQP) · Dental Low-Speed Turbine Handpiece (Model: LN, L) | 5 | 2026 |
| Satelec - Acteon Group | United States | Maker | Air-N-Go by Satelec Air-N-Go Easy by Satelec · handpiece Air Powered Dental | 18 | 2024 |
| Dentalez, Inc. | United States | Maker | Concentrix MX Handpiece - 265630 · DentaLube II - 262539 · HiFlo Fiber Optic Swivel · LED Plug N Play Swivel Assembly · +25 | 9 | 2026 |
| Lares Research | United States | Maker | L5 557 ProStyle SF NSK SC · L5 557 ProStyle SF NSK SLC · L5 757 ProStyle SF NSK SC · L5 757 ProStyle SF NSK SLC · +67 | 8 | 2022 |
| Handpiece Headquarters | United States | Maker | Dental Handpiece Cleaner and Lubricant · DHR · HHC · Medidenta Air King · +5 | 7 | 2024 |
| Ttbio Corp. | Taiwan | Maker | ECO 105, ECO 101 4T4, ECO 101 4M4 · EVO 450 M4 · EVO 450, EVO 450L, EVO 450K, EVO 450KL, EVO 450N, EVO 450NL, EVO 450S, EVO 450SL, EVO 450ST, EVO 450STL · EVO 450W, EVO 450WL, EVO 450B, EVO 450BL, EVO 450MW, EVO 450MWL, EVO 450MR, EVO 450MRL · +16 | 6 | 2023 |
| Foshan Topmed Dental Co., Ltd. | China | Maker | 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) · High speed air turbine handpiece (TM-T1B2, TM-T1M4, TM-T2B2, TM-T2M4, TM-T3B2, TM-T3M4, TM-T4B2, · TM-T4M4, TM-T6B2, TM-T6M4) | 2 | 2026 |
| Osteomed, LLC | United States | Maker | — | 26 | 2022 |
| W&H Dentalwerk Buermoos GmbH | Austria | Maker | — | 17 | 2026 |
| Codent Technical Industry Co., Ltd. | Taiwan | Maker | CODENT DENTAL AIR-POWERED HANDPIECE, MODEL HPS · CODENT LOW SPEED DENTAL HANDPIECES AND ACCESSORIES · High Speed Handpieces And Accessories | 5 | 2024 |
| Foshan Cicada Dental Instrument Co, Ltd. | China | Maker | CV/GX644, CV/GX652, CV/GX654, GK01L, GK02L, GK03L, GK45L, GN02L, GN45L, GN01, G401, G402, G445, G406, G408, G409, G410, · G201, G245, G206, G208, G209, G210 · High Speed Handpiece: CV/GX602, CV/GX604, CV/GX612, CV/GX, CV/GX622, CV/GX624, CV/GX632, CV/GX634, CV/GX642 · Low Speed Handpiece:CV/DX, CV/DX802,J05/D05M/D05Z,J03W/D05M/D05Z, J04/D05M/D05Z, D02W/D02M/D02Z, Z45L/D02M/D02Z, · +1 | 4 | 2022 |
| KaVo Dental GmbH | Germany | Maker | 0.535.5200 - INTRA-L-MOTOR 181 H · 0.535.5210 - INTRA L-LUX 181 L · 0.535.5250 - INTRAmatic 181 M · 0.535.5260 - INTRA 181 K 20 000 R.P.M. · +101 | 2 | 2021 |
| Foshan SOCO Precision Instrument Co.,Ltd. | China | Maker | Air Motors: SCHD16-M, SCHD17-M, SCHD24-M, SCHD27-M) · Dental Low Speed Handpieces including Straight and Geared Angle Handpieces and Air Motors Straight Handpieces: SCHD24-S · Dental Low Speed Handpieces including Straight and Geared Angle Handpieces and Air Motors Straight Handpieces:SCHD17-S · Dental Low Speed Handpieces including Straight and Geared Angle Handpieces and Air Motors Straight Handpiecess:SCHD16-S · +14 | 1 | 2024 |
| Litu Tech Ltd. | China | Maker | High Speed Air Turbine (Model:Max ST 4H Mini; Max 4H; Max T; Mini Max 45 4H; Mini Max 45; Mini Max QC; Max Torque QC ) · High Speed Air Turbine (Model:Mini Max Torque; Mini OPT; Mini OPT Torque ) · High Speed Air Turbine Handpiece (Model: G100,G200,G300,G400,G450,G500,G600,G700,G700L,G800,G800L) | 1 | 2024 |
| Electro Medical Systems SA | United States | Maker | AIR-FLOW HANDY 2+ · AIR-FLOW handy 3 · AIR-FLOW handy 3 PERIO · AIR-FLOW handy 3 PLUS · +4 | 5 | 2002 |
| Rolence Ent., Inc. | Taiwan | Maker | Dental High Speed Handpiece · ROLENCE | 5 | 2009 |
| CNC Manufacturing, Inc. | United States | Maker | Lynx - High-Speed Handpiece · Lynx - Low-Speed Handpiece · Lynx Contra Sheath · Lynx High-Speed Handpiece · +5 | 5 | 2007 |
| Micron Corporation | Japan | Maker | Quick Jet M | 5 | 2018 |
| Anodia Systems | United States | Maker | Cutting Fluid System for Dental High Speed Drills · CUTTING FLUID SYSTEM FOR HIGH SPEED HANDPIECE · Mint-A-Kleen (MAK-OZ) Dental Unit Waterline Cleaner · Steri-Sol · +3 | 4 | 2003 |
| Premium Plus International Limited | Hong Kong SAR China | Maker | Premium Plus · Pro-Sys Hygiene Handpiece · Prophy Air Motor · 1002-4 | 3 | 2017 |
| Preventive Technologies, Inc. | United States | Maker | ESA® mate slow speed air driven motor | 3 | 2014 |
| MK-dent GmbH | Germany | Maker | AM0002 Airmotor, 2 holes, 2000 rpm · AM0004 Airmotor, 4 holes, 2000 rpm · AM0012 Airmotor, 2 holes, 2000 rpm · AM0014 Airmotor, 4 holes, 2000 rpm · +125 | 2 | 2005 |
| Sable Industries, Inc. | Canada | Maker | Access II · Access K4 · Access K6 · Access KL · +49 | 2 | 2009 |
| Dental Technologies, Inc. | United States | Maker | — | 2 | 2013 |
| Shanghai Dental Instrument Factory Co., Ltd. | China | Maker | CST61 · HIGH SPEED TURBINE | 2 | 2006 |
| MicroP Technology (Taiwan), Inc. | Taiwan | Maker | Dental Handpieces and Accessories HALLEY Series · Dental High-speed Handpiece HALLEY Series | 2 | 2021 |
| Peng Lim Enterprise Co., Ltd. | Taiwan | Maker | DENTAL HANDPIECE | 2 | 2006 |
| Bien-Air Dental, SA | Switzerland | Maker | ADAPTER · AQUACARE · BUR GUARD HP 1:2 (100 PCES) · CA · +194 | 1 | 2009 |
| Gebr. Brasseler GmbH & Co. KG | Germany | Maker | KOMET OSCILLATING CONTRA-ANGEL · KOMET SONIC HANDPIECE · W&H, Synea, Oscillating Contra Angle | 1 | 2007 |
| Nakamura Dental Handpiece Mfg. Co., Ltd. | Japan | Maker | ACCLEAN · HyGenie · ND · Prophy Sport · +4 | 1 | 2012 |
| Osseo Scientific, LLC | United States | Maker | AIR POWERED DENTAL HANDPIECE · Contra Angles and Dental Heads · Dental Handpieces and Turbines · Dental Highspeed and Turbines · +1 | 1 | 2007 |
| Foshan Wenjian Medical Instrument Co., Ltd. | China | Maker | High-speed air turbine handpiece (model: WJ-114, WJ- 112, WJ-124, WJ -122, WJ- 134, WJ -132, WJ - 144) · High-speed air turbine handpiece (model: WJ-142, WJ-154, WJ-152, WJ-164, WJ-162) · Low-speed air turbine handpiece (WJ-414, WJ-412, WJ-424, WJ-422) | 1 | 2020 |
| Filmtech | United States | Maker | BRIXTON | 1 | 1996 |
| Microtech | United States | Maker | Dentex | 1 | 2002 |
| Beyes Dental Inc | Canada | Maker | AirLight Series Dental Handpieces · Beyes Dental Maxso Lowspeed handpiece · Electric Handpiece System: E600P; E800P; E800B; X99L · MAXSO Series Dental Handpiece | — | — |
| J. Morita MFG Corp. | Japan | Maker | Air Solfy · AIR TORX · ARETE Handpiece Maintenance Unit · LUBRICARE · +5 | — | — |
| Onvet Medical Canada Inc. | Canada | Maker | AMW AirPeak G100, G200, G200X;G300, G400,MT05;MT20; P100; AMW iTesla G500, G600, G700, G800,MT40 | — | — |
| LM-Instruments Oy | Finland | Maker | — | — | — |
| SycoTec GmbH & Co KG | Germany | Maker | Midwest Plus Automate Spray · Midwest® 6-pin Coupler, K-style CE · STATIS, ML and SL · STATMATIC 31 | — | — |
| EMS Electro Medical Systems SA | Switzerland | Maker | AIR-FLOW HANDY 2+ · AIR-FLOW HANDY 3 · AIR-FLOW HANDY 3 PERIO · PERIO-FLOW NOZZLE | — | — |
| Sinol Dental Limited | China | Maker | Dental Low Spped Handpiece includin · High Speed Air Turbine Handpiece Se | — | — |
| Petoskey Plastics | United States | Maker | Dental Chair Cover non sterile | — | — |
| Integrated Solutions, Inc. | United States | Maker | BioLube | — | — |
| Proguard Health Inc. | United States | Maker | — | — | — |
| TUNAP GmbH & Co. KG | Germany | Maker | — | — | — |
| Nobel Biocare Services AG | Switzerland | Contract manufacturer | CA | 94 | 2026 |
| Shofu Inc | Japan | Contract manufacturer | LAB AIR Z HANDPIECE | 96 | 2025 |
| Ultradent Products, Inc. | United States | Contract manufacturer | Ultrapro Tx Air Hygiene Handpiece · Ultrapro TX Air Motor and Nose Cones | 95 | 2026 |
| Pac-Dent Inc. | United States | Contract manufacturer | Medidenta High Speed Handpieces | 5 | 2022 |
| Keystone Industries | United States | Contract manufacturer | Prophybrite Air Polishing Unit | 2 | 2025 |
| A-dec, Inc. | United States | Manufacturer | Air High Speed Handpieces · Air Low Speed Handpiece · Alegra · AM-20 MW · +15 | 68 | 2022 |
| Coltene/Whaledent AG | Switzerland | Contract manufacturer | K-Spray Handpiece Spray · STATCARE Handpiece Spray · STATMATIC Spray | 45 | 2022 |
| DCI International LLC | United States | Manufacturer | NSK Air High Speed Coupler PTL-CL-LED · NSK Air High Speed M800L · NSK Air High Speed M800L Bundle · NSK Air High Speed M900L · +16 | 1 | 2025 |
| Aseptico, Inc. | United States | Contract manufacturer | AHP-50MK - MOTOR AIR 4-HOLE E-TYPE 20K RPM = MK-Dent PN# AM0004 Airmotor, 4 holes, 2000 rpm · AHP-63MK - HANDPIECE 1:1 CONTRA LATCH = MK-Dent PN# LB11/11C BASIC LINE Contra Angle Handpiece · AHP-72MK-FO - HANDPIECE 1:5 CONTRA W/FO & WATER INCREASER = MK-Dent PN# LE15L ECO LINE Contra Angle Handpiece with Light · AHP-82MK-QD - HANDPIECE KAVO 6-PIN LED FO QUICK COUPLER = MK-Dent PN# QC6016KW Quick Connector, 4 holes (6 pins) · +2 | 17 | 2015 |
| Tpc Advanced Technology, Inc. | United States | Repacker / relabeler | TPC Air Driven Dental Drill | 3 | 2007 |
| Integra LifeSciences Corporation | United States | Contract manufacturer | Miltex | 2 | 2014 |
| Vector Research & Development | United States | Repacker / relabeler | Vector | 1 | 2002 |
| Dental Savings Club Inc. | Canada | Foreign exporter | — | 1 | 2016 |
| Sotera Health LLC | United States | Contract manufacturer | HAND PIECE · Peak PlasmaBlade TnA | — | — |
| Jersey Dental Supplies | United States | Repacker / relabeler | KAVO SPRAY | — | — |
| TitanLinks Logistics LLC | United States | Repacker / relabeler | dental lubricant · Handpiece | — | — |
| Jmu Dental, Inc. | United States | Repacker / relabeler | COXO Handpiece, X TITAN Handpiece · JMU Dental High-speed Turbine Handpiece | — | — |
| Patterson Companies, Inc. | United States | Foreign exporter | Handpiece, air-powered, dental · LUBRICARE; LUBRINA; STERLING · MASTERtorque LUX M8900 L; 111.2330 - MASTERtorque Mini Kids-Edition en; 301000 - MASTERtorque Mini LUX M8700 L; 3. · Patterson Dental Handpiece · +8 | — | — |
| Soher Med Limited | Hong Kong SAR China | Foreign exporter | dental lubricant | — | — |
| Samtrade Supplies Inc. | Canada | Foreign exporter | Kavo Spray | — | — |
| Nordent MFG., Inc. | United States | Contract manufacturer | AP-H, AP-H Plus | — | — |
| GoldenDent | United States | Repacker / relabeler | Dental Air Polishing Handpiece | — | — |
| Flight Dental Systems USA Inc. | United States | Repacker / relabeler | AM0002 Airmotor, 2 holes, 2000 rpm; AM0004 Airmotor, 4 holes, 2000 rpm; AM0012 Airmotor, 2 holes, 2000 rpm; AM0014 · Bold Series Highspeed Handpiece - F-160K · Bold Series Highspeed Handpiece - F-170K, F-160, F-164, F-164T, F-170KT, QC-164K, QC-170, F-140, F-161K, F-162K, F-163K · CLASSIC LINE High Speed Handpiece with Light; HC8021K PRIME LINE High Speed Handpiece; HE11 ECO LINE; HE12 ECO LINE · +24 | — | — |
| Yizur Ltd | Hong Kong SAR China | Foreign exporter | Handpiece | — | — |
| Ads Dental System Inc. | United States | Remanufacturer | AP-H; AP-H Plus | — | — |
| Toyo Medical Co. | United States | Repacker / relabeler | nakanishi · TOYO MEDICAL CO | — | — |
| Henry Schein MSO, LLC | United States | Repacker / relabeler | Anthogyr · Bien Air · Bien-Air · Dentsply Sirona · +10 | — | — |
| W&H Impex Inc. | Canada | Foreign exporter | Advanced Air System | — | — |
| Sanicure BV | Netherlands | Foreign exporter | Handpiece, air-powered, dental | — | — |
| Zapalign LLC | United States | Repacker / relabeler | Handpiece, air-powered, dental | — | — |
| Peter Brasseler Holdings, LLC | United States | Contract manufacturer | — | — | — |
| Head Dental Corp. | United States | Repacker / relabeler | Handpiece, air-powered, dental | — | — |
| 3D Dental Designs and Development LLC | United States | Contract manufacturer | — | — | — |
| Mainline Medical Dental Supply | Canada | Foreign exporter | — | — | — |
| Oketz Logistics LLC | United States | Repacker / relabeler | — | — | — |
| Swedent Dental Wholesale Group | United States | Repacker / relabeler | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 1 Oct 2026 | K260029 | Firstar Dental Handpieces | Firstar Dental Company |
| 23 Sep 2026 | K262144 | DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor Handpiece | Setagaya Seiki Co., Ltd. |
| 12 Jan 2026 | K251389 | High speed air turbine handpiece | Foshan Topmed Dental Co., Ltd. |
| 12 Jan 2026 | 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. |
| 28 Feb 2025 | K242179 | Synea Fusion Handpieces (Intensiv & Profin) | W&H Dentalwerk Bürmoos GmbH |
| 13 Nov 2024 | K240337 | Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L) | Guangdong JINME Medical Technology Co., Ltd. |
| 12 Nov 2024 | 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. |
| 20 Sep 2024 | K241880 | Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing System (Perio Mate Nozzle Tip) | Nakanishi, Inc. |
| 30 Apr 2024 | K233122 | High Speed Air Turbine Handpiece (G100,G200,G300,G400,G450,G500,G600,G700,G700L,G800,G800L) | Litu Tech Ltd. |
| 25 Apr 2024 | K233308 | Air Motor (Model name: FX204 M4); Air Motor (Model name: M205) | Nakanishi, Inc. |
| 22 Sep 2023 | K220179 | High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air Motors | Foshan COXO Medical Instrument Co., Ltd. |
| 23 Aug 2023 | K232243 | EVO 700 series high speed handpiece | Ttbio Corp. |
| 2 Jun 2023 | K230888 | Titanium Turbine | Nakanishi, Inc. |
| 22 Feb 2023 | K221741 | TRAUS Air Dental Handpiece | Saeshin Precision Co., Ltd. |
| 12 Dec 2022 | K202674 | Medidenta High Speed Handpieces | Pac-Dent Inc. |
| 17 Nov 2022 | K212910 | Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece | Shenzhen Carejoy Technology Co., Ltd. |
| 28 Sep 2022 | K221548 | Dental Air Polishing Handpiece | Guilin Woodpecker Medical Instrument Co., Ltd. |
| 15 Jul 2022 | K221814 | OK Handpiece | Jaintek Co.,Ltd |
| 21 Jun 2022 | K203791 | Stainless Turbine | Nakanishi, Inc. |
| 8 Nov 2021 | K202371 | Highspeed Airturbine Handpiece | Beijing Dongbo Dental Handpiece Co., Ltd. |
| 3 Sep 2021 | K202786 | Dental Low-speed Handpieces and Accessories | MicroP Technology (Taiwan), Inc. |
| 11 Aug 2020 | K193264 | Disposable High Speed Air Turbine Handpiece | Ningbo Hpdove Dental Instruments Co., Ltd. |
| 26 May 2020 | K181691 | High-speed air turbine handpiece / Low-speed air turbine handpiece | Foshan Wenjian Medical Instrument Co., Ltd. |
| 4 Mar 2020 | K190509 | Lubrina 2 | J. Morita USA, Inc. |
| 13 Jan 2020 | K192409 | Midwest Rhino XE and Air Motor M | Dentsply Sirona, Inc. |
| 6 Jan 2020 | 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. |
| 11 Dec 2019 | K190508 | EVO 450 series High Speed Handpieces | Ttbio Corp. |
| 9 Dec 2019 | K181900 | Dental high speed handpiece, Dental low speed handpiece | Foshan Cicada Dental Instrument Co, Ltd. |
| 10 Apr 2019 | K181110 | PROPHYflex 4 | Kaltenbach & Voigt GmbH |
| 24 Jul 2018 | K173943 | Dental High-speed Handpiece and Accessories | MicroP Technology (Taiwan), Inc. |
| 11 Jul 2018 | K172543 | High-speed Turbine Handpieces for Single Use | Beijing Dongbo Dental Handpiece Co., Ltd. |
| 28 Mar 2018 | K173465 | Concentrix MX-AC High-Speed Handpiece | Dentalez, Inc. |
| 18 Dec 2017 | K171174 | PERIO-FLOW nozzle | E.M.S Electro Medical Systems S.A |
| 8 Dec 2017 | K171553 | W&H Assistina Twin | W&H Dentalwerk Buermoos GmbH |
| 21 Nov 2017 | K170236 | Dental Low-speed Turbine Handpiece | Guangdong JINME Medical Technology Co., Ltd. |
| 8 Nov 2017 | K170229 | Dental High-speed Turbine Handpiece | Guangdong JINME Medical Technology Co., Ltd. |
| 19 Oct 2017 | K170261 | Premium Plus Prophy Air Motor | Premium Plus International Limited |
| 15 Aug 2017 | K163483 | PANA SPRAY Plus | Nakanishi, Inc. |
| 23 Feb 2017 | K162926 | Air-Powered Handpieces and Handpiece Attachments | W&H Dentalwerk Bürmoos GmbH |
| 29 Sep 2016 | K160410 | WOlf High Speed Handpieces - Medium head, WOlf High Speed Handpieces - Small head | Dental Savings Club Inc. |
| 8 Apr 2016 | K153411 | 430 Torque High-Speed Handpiece Series - 430 SWL Torque High Speed Handpiece, 430 SW Torque High Speed Handpiece | Dentalez, Inc. |
| 3 Feb 2016 | K151912 | AIR-FLOW handy 3.0 PLUS | E.M.S Electro Medical Systems S.A |
| 8 Dec 2015 | K152146 | High Speed Handpieces and Accessories | Codent Technical Industry Co., Ltd. |
| 23 Nov 2015 | K143704 | Advanced Air System | W&H Dentalwerk Buermoos GmbH |
| 13 May 2015 | K141886 | MDK HANDPIECES | Modern Korea Co., Ltd. |
| 4 May 2015 | K141576 | Maxima PRO 45L | Kavo DO Brasil Industria E Comercio Ltda |
| 24 Apr 2015 | K150798 | Codent Low Speed Dental Handpieces and Accessories | Codent Technical Industry Co., Ltd. |
| 27 Feb 2015 | K141183 | EVO 500 SERIES HIGH SPEED HANDPIECES/TIGER 500/300/101 SERIES HIGH SPEED HANDPIECES | Ttbio Corp. |
| 17 Feb 2015 | K143183 | Maxima XTEND Handpiece Maintenance System | Handpiece Headquarters |
| 28 Oct 2014 | K142063 | #8C RENEGADE DENTAL HANDPIECE | Handpiece Club, LLC |
| 28 Oct 2014 | K141221 | LARES ULTRALITE PROSTYLE HIGH-SPEED DENTAL HANDPIECES, LARES EURO PROSTYLE HIGH-SPEED DENTAL HANDPIECES, LARES TURBO+ PR | Lares Research |
| 24 Oct 2014 | K133069 | CODENT LOW SPEED DENTAL HANDPIECES AND ACCESSORIES | Codent Technical Industry Co., Ltd. |
| 30 May 2014 | K131319 | T1/T2/T3 TURBINE FAMILY | Dentsply Sirona, Inc. |
| 11 Apr 2014 | K132478 | AIR-FLOW HANDY 3.0 | E.M.S Electro Medical Systems S.A |
| 28 Mar 2014 | K133170 | QUICK JET M | Micron Corporation |
| 24 Feb 2014 | K132480 | AIR-FLOW HANDY 3.0 PERIO | E.M.S Electro Medical Systems S.A |
| 27 Sep 2013 | K130560 | MASTERTORQUE LUX 8900 L | Kaltenbach & Voigt GmbH |
| 25 Sep 2013 | K130455 | 430 SWL 45 AND 430 SW 45 HIGH-SPEED HANDPIECES | Dentalez Group, Stardental Division |
| 12 Aug 2013 | K131014 | PANA SPRAY PLUS | Nakanishi, Inc. |
| 29 Jun 2012 | K120218 | TEK USA E-GENERATOR INTEGRATED LED HANDPIECE (HIGH & LOW SPEED AIR TURBNINE DENTAL HANDPIECE) | Palm Beach Dental Supply D/B/A Tek USA |
| 20 Jun 2012 | K112024 | TI-MAX X450 | Nakanishi, Inc. |
| 5 Apr 2012 | K113674 | SPRAY & CLEAN HANDPIECE CLEANER& LUBRICANT MAXIMA HANDPIECE CLEANER & LUBRICANT EZCARE HANDPIECE CLEANER & LUBRICANT | Handpiece Headquarters, Inc. - Hpr, Inc. |
| 5 Mar 2012 | K113655 | TI-MAX X TURBINE | Nakanishi, Inc. |
| 23 Feb 2012 | K113222 | ND LOWSPEED AIRMOTOR,ND HIGHSPEED AIRTURBINE HANDPIECE | Nakamura Dental Handpiece Mfg. Co., Ltd. |
| 8 Feb 2012 | K111249 | ORTHOSLENDERIZER | Orthomatics, Inc. |
| 7 Feb 2012 | K112673 | PROPHY-MATE NEO | Nakanishi, Inc. |
| 23 Jan 2012 | K113301 | CONCENPIECE,HIGH-SPEED HANDPIECE SERIES | Dentalez, Inc. |
| 16 Dec 2011 | K112869 | EASYPROPHY SERIES AIR POLISH DEVICES, MODELS EASYPROPHY 200 AND EASYPROPHY 400 | Beyes Dental Canada, Inc. |
| 16 Dec 2011 | K112623 | AIRLIGHT DENTAL HANDPIECE | Beyes Dental Canada, Inc. |
| 8 Dec 2011 | K110379 | AIR-N-GO | Satelec |
| 27 Apr 2011 | K102517 | TIGER 500 SERIES HIGH SPEED HANDPIECES AND ATTACHMENTS | Thunder Tiger Corp. |
| 3 Dec 2010 | K100731 | BOSWORTH AIR POLISHER | Harry J. Bosworth Co. |
| 9 Sep 2010 | K101551 | PACEMAKER HIGH-SPEED HANDPIECE MODEL PM-MQ, PM-M | Delma Medical Instrument (Guangzhou) Co., Ltd. |
| 20 Aug 2010 | K101717 | DENTAL HANDPIECES, MODELS: KARAM STD/MINI; BREEZE STD/MINI: KARAM 45; DEXOR 45; KARAM 4H COUPLING | Aerobine, Inc. |
| 12 Aug 2010 | K100389 | HHC PUSH-BUTTON REPLACEMENT TURBINE FOR MIDWEST TRADITION HANDPIECE MODEL MW TURBINE REPLACEMENT | Handpiece Headquarters |
| 3 Jun 2010 | K100833 | SYLE SMARTIP | Osspray, Ltd. |
| 22 Apr 2010 | K093971 | DENTAL HANDPIECE | North West Medical Instrument (Group) Co., Ltd. |
| 5 Apr 2010 | K093341 | CENTURY MODEL 105C | Sybron Dental Specialties |
| 14 Jan 2010 | K092933 | SAF (SELF ADJUSTING FILE) | Redent Nova, Ltd. |
| 28 Dec 2009 | K093072 | STARCARE HANDPIECE MAINTENANCE UNIT | Dentalez, Inc. |
| 16 Dec 2009 | K093084 | ROLENCE DENTAL HIGH SPEED HANDPIECE, RHP | Rolence Ent., Inc. |
| 20 Oct 2009 | K092289 | EMS AIR-FLOW HANDY PERIO | E.M.S Electro Medical Systems S.A |
| 16 Oct 2009 | K091065 | AIR TORX, MODEL TRA-200, TRA-200-CP3, TRA-200-CP4 | J. Morita USA, Inc. |
| 30 Jun 2009 | K090548 | CONTRA-ANGLE HANDPIECE KOMET OS30 | W&H Dentalwerk Buermoos GmbH |
| 27 Feb 2009 | K090369 | PRODRIVE LINE OF DENTAL HANDPIECES | Prodrive Systems, Inc. |
| 23 Feb 2009 | K083101 | PREMIUM SLOW SPEED; 20K AIR MOTOR, HEADS, CONTRA-ANGLES, STRAIGHT NOSECONES | Sable Industries, Inc. |
| 18 Feb 2009 | K082791 | EMS AIR-FLOW MASTER | E.M.S Electro Medical Systems S.A |
| 21 Jan 2009 | K081811 | CARE3 PLUS | Nakanishi, Inc. |
| 15 Jan 2009 | 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. |
| 7 Jan 2009 | K082827 | A-DEC/W&H PROFIN RECIPROCATING CONTRA-ANGLE HANDPIECE ATTACHMENT | A-dec, Inc. |
| 11 Sep 2008 | K080682 | HHC, SCORE, HENRY SCHEIN CANISTER HANDPIECE | Handpiece Headquarters, Inc. - Hpr, Inc. |
| 3 Sep 2008 | K073478 | SUPERTORQUE HIGH-SPEED HANDPIECES AND GENTLEPOWER HANDPIECES AND ATTACHEMENTS | Sybron Dental Specialties |
| 20 Mar 2008 | K073652 | ND LOW SPEED AIRMOTOR AND HANDPIECE, HIGHSPEED AIRTURBINE HANDPIECE, E-TYPE STRAIGHT NOSECONE AND CONTRA ANGLE | Nakamura Magnifier Co., Ltd. |
| 7 Feb 2008 | K080240 | CHALLENGER/CLASSIC PUSH BUTTON HANDPIECE | Promident, LLC |
| 4 Feb 2008 | K073319 | STATMATIC 31 HANDPIECE MAINTENANCE UNIT | Coltene/Whaledent AG |
| 28 Jan 2008 | K072989 | AXIS SYSTEM | Dentsply Intl., Inc. |
| 25 Jan 2008 | K072754 | AXENIC DHP DISPOSABLE HIGH-PERFORMANCE HANDPIECE | Axenic Dental, Inc. |
| 14 Dec 2007 | K073284 | AIR-FLOW MASTER STANDARD | (Ems Sa) Electro Medical Systems |
| 7 Dec 2007 | K073353 | DO-ALL DENTAL HANDPIECE LUBRICANT | Prodrive Systems, Inc. |
| 14 Nov 2007 | K072554 | ACCESS AND ROTAMAX FIBER OPTIC HIGH SPEED DENTAL HANDPIECES | Sable Industries, Inc. |
| 12 Oct 2007 | K071561 | HI-SPEED TURBINE HANDPIECES, MODEL GSO1-B,GSO2-B,GSO3-B,GSO1-D,GSO2-D | Beijing North Pole Dental Handpiece Co., Ltd. |
| 13 Sep 2007 | K071891 | STATIS DENTAL HANDPIECES | Coltene/Whaledent AG |
| 10 Sep 2007 | K071965 | I-SURGE | Satelec |
| 5 Jul 2007 | K070663 | A-DEC/W&H SYNEA AIR-DRIVEN HIGHSPEED HANDPIECE, MODEL TA-98, TA-97, A-DEC/W&H SYNEA HANDPIECE ATTACHMENT | A-dec, Inc. |
| 15 Jun 2007 | K070869 | PROPHY STAR 3 HYGIENE HANDPIECE, MODEL 264422 | Dentalez, Inc. |
| 31 May 2007 | K070074 | LUBRINA, MODEL HIM-1 | J. Morita USA, Inc. |
| 5 Feb 2007 | K070297 | CLEARVIEW DENTAL HANDPIECE LUBRICATOR AND LUBRICANT | Dental Air Solutions of Nc, Inc. |
| 2 Feb 2007 | K070001 | MASTER CLASSIC 5K LOW SPEED HANDPIECE, 20K LOW SPEED HANDPIECE, TM5 LOW SPEED HANDPIECE AND TM20 LOW SPEED HANDPIECE | CNC Manufacturing, Inc. |
| 25 Jan 2007 | K070155 | INTEGRITY LOW SPEED DENTAL AIR HANDPIECE AND ATTACHMENT, MODELS: MOTOR INT-E, MOTOR INT-D AND ATTACHMENT INT-SNC | Osseo Scientific, LLC |
| 14 Dec 2006 | K062947 | HIGH SPEED AIR TURBINE HANDPIECE, MODELS SUPER-AIR AND SUPER-QD SERIES | Peng Lim Enterprise Co., Ltd. |
| 28 Nov 2006 | K062812 | DENTAL AIR-POWERED HANDPIECE, MODELS TIGER 300T, 300K, 300W, 300B AND 300N | Thunder Tiger Corp. |
| 2 Nov 2006 | K062740 | JINDELL HIGH SPPED AIR TURBINE HANDPIECE, MODELS SW, SP, SU, ETU, MU | Jindell Medical Instruments Co., Ltd. |
| 26 Oct 2006 | K063110 | CST61 HIGH SPEED TURBINE HANDPIECE | Shanghai Dental Instrument Factory Co., Ltd. |
| 19 Oct 2006 | K062418 | K-SPRAY, MODEL 085-2715 | Coltene/Whaledent AG |
| 4 Aug 2006 | K062219 | PRODRIVE SYSTEMS REPLACEMENT TURBINE | Prodrive Systems, Inc. |
| 29 Mar 2006 | K053368 | INTERPROXIMAL REDUCTION SYSTEM | Dentsply International, Inc. |
| 20 Jan 2006 | K052822 | DENTAL AIR-POWERED HANDPIECE, MODELS TIGER 100, 101, 200, 201 AND 202 | Thunder Tiger Corp. |
| 20 Dec 2005 | K052700 | PANA-SPRAY | Nakanishi, Inc. |
| 3 Oct 2005 | K051872 | MK-DENT LOW SPEED HANDPIECES AND ACCESSORIES INCLUDING SPARE PARTS, TUBINGS, AND LIGHT POWER SYSTEM, MODELS: LS2011 | MK-dent GmbH |
| 21 Mar 2005 | K043497 | 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 | J. Morita USA, Inc. |
| 16 Feb 2005 | K043498 | TWIN POWER TURBINE HIGH SPEED AIR TURBINE DENTAL HANDPIECE | J. Morita USA, Inc. |
| 17 Dec 2004 | K042787 | IS 40 MICROMOTOR | Satelec |
| 22 Oct 2004 | K041755 | CROMAX HIGH SPEED TURBINE HANDPIECE | J.R. Medical Technologies, Inc. |
| 16 Jun 2004 | K041141 | DENTSPLY CAVITRON JET WAVE AIR POLISHING PROPHYLAXIS SYSTEM, MODEL G125 | Dentsply Intl., Inc. |
| 23 Feb 2004 | K033812 | SIROAIR L AIR SCALER | Dentsply Sirona, Inc. |
| 6 Feb 2004 | K033213 | CODENT DENTAL AIR-POWERED HANDPIECE, MODEL HPS | Codent Technical Industry Co., Ltd. |
| 17 Oct 2003 | K032395 | PROPHY-MATE | Nakanishi, Inc. |
| 2 Oct 2003 | K032234 | MK-DENT HIGH SPEED DENTAL HANDPIECE, MODELS HS 4021K, 4011K, 4012K, AND HS 6021K, 6011K, 6012K | MK-dent GmbH |
| 1 Aug 2003 | K031851 | DENTISEPTIC HPC | Bethel, Inc. |
| 15 Jul 2003 | K031145 | ESTYLUS ELECTRIC MOTOR SYSTEM | Dentsply Intl., Inc. |
| 9 Jul 2003 | K031868 | PROPHYPEARLS | Kavo America |
| 22 Oct 2002 | K022535 | MICROTECH PUSH BUTTON HANDPIECE, MODEL MHS-A100 | Microtech |
| 25 Jul 2002 | K022119 | EMS AIR-FLOW HANDY 2 DENTAL HANDPIECE | Electro Medical Systems SA |
| 26 Jun 2002 | K012308 | KAVO QUATTROCARE | Kavo America |
| 8 Nov 2001 | K012720 | TULSA CONTRA ANGLES | Dentsply Intl., Inc. |
| 5 Oct 2001 | K010127 | W & H ASSISTINA | A-dec, Inc. |
| 9 Jan 2001 | K003518 | RAPIDD HIGHSPEED DENTAL HANDPIECE | Dentsply Intl., Inc. |
| 14 Dec 2000 | K000834 | CASTELLNI AIR POWERED HANDPIECES SYRINGES: THREE STERIL, MULTISTERIL TURBINS: CLEANAIR, CLEANLIGHT MICROMOTORS: IMPLANTO | Castellini S.P.A. |
| 5 Oct 2000 | K000848 | TDK HANDPIECES | Orasystems |
| 27 Sep 2000 | K000847 | ORALUBE | Orasystems |
| 11 May 2000 | K000710 | MD 10, SEM, SM 12, CBM | Nouvag AG |
| 3 May 2000 | K000547 | ATR TECNIKA | Advanced Technology Research (A.T.R.) S.R.P. |
| 4 Apr 2000 | K000049 | SUNI MAX | Satelec |
| 11 Jan 2000 | K993526 | SYNEA - LS LOW-SPEED HANDPIECE | A-dec, Inc. |
| 11 Jan 2000 | K971732 | DENTAL HANDPIECE | Pauline M. Nicholls |
| 15 Dec 1999 | K991401 | ATR 3000, ATR 2000, IMPLANT-PRO | Advanced Technology Research (A.T.R.) S.R.P. |
| 2 Dec 1999 | K991492 | LC COMPOSITE | Harry J. Bosworth Co. |
| 13 Oct 1999 | K992380 | ENDO-EZE MOTOR AND HANDPIECE | Ultradent Products, Inc. |
| 7 Oct 1999 | K991857 | AIRFLOW HANDY | Electro Medical Systems SA |
| 10 Sep 1999 | K992011 | SYNEA-HS HIGH SPEED-HANDPIECE | A-dec, Inc. |
| 10 Aug 1999 | K991701 | MACH-SIGMA HANDPIECE, ULTRAPUSH, MODELS MACH-SIGMA MU (MINI HEAD), MACH-SIGMA SU (STD. HEAD), MACH-SIGMA TU (TORQUE HD) | Nsk Nakanishi, Inc. |
| 23 Feb 1999 | K984244 | ORL-E-92 SURGICAL DRILL SYSTEM | Bien Air USA, Inc. |
| 9 Feb 1999 | K981679 | TCM 3000 AND TCM ENDO | Nouvag AG |
| 10 Dec 1998 | K983183 | GYRO LONG-LIFE,BLACK PEARL ECO, ONDINE &CROMA, PRESTIGE, BORA, AQUILON, MC2,MC3, BASCH, ISOLITE, OPTIMA, US, PLPE, CA, P | Bien Air USA, Inc. |
| 18 Nov 1998 | K983168 | AVANT HIGH SPEED HANDPIECE, AVANT FIBER OPTIC HIGH SPEED HANDPIECE, MODEL #'S AVANT HS 100 & AVANT HS 200 | Ora Innovations, Inc. |
| 22 Oct 1998 | K982593 | LUBE FREE AUTOCHUCK TURBINE WITH VORTEX AIR SEAL FOR USE WITH STAR DENTAL 430 SERIES LUBE FREE HIGH SPEED DENTAL HANDPIE | Dentalez Group |
| 8 Oct 1998 | K980585 | MILLENNIUM | Biolase Technology, Inc. |
| 2 Sep 1998 | K982050 | MODEL MS-2 HANDPIECE | Parkell, Inc |
| 11 Aug 1998 | K981869 | PRO-FLEX DISPOSABLE PROPHY ANGLE | Professional Dental Mfg., Inc. |
| 22 Jun 1998 | K981990 | MRS-400, MAXI 400, MRSL-400, MAXI 400L | D.B.I. America Corp. |
| 5 Jun 1998 | K980162 | MACH-SIGMA HANDPIECE, ULTRAPUSH | Nsk Nakanishi, Inc. |
| 13 Mar 1998 | K974670 | ATHENA 1:1 CONTRA ANGLE, ATHENA 4:1 CONTRA ANGLE, ATHENA 16:1 CONTRA ANGLE, ATHENA 64:1 CONTRA ANGLE, ATHENA 16-: CONTRE | Athena Technology, Inc. |
| 11 Mar 1998 | K974671 | ATHENA 20R S TYPE SLOW SPEED HANDPIECE MOTOR | Athena Technology, Inc. |
| 19 Dec 1997 | K973876 | PROPHYFLEX 2, MODEL 2012 | Kavo America |
| 22 Sep 1997 | K972436 | T1 LINE DENTAL HANDPIECES | Siemens AG |
| 10 Sep 1997 | K972376 | IMPACT AIR 45 HANDPIECE FOR PERIODONTAL USE | Glenwood, LLC |
| 10 Sep 1997 | K972375 | IMPACT AIR 45 HANDPIECE FOR ENDODONTIC USE | Glenwood, LLC |
| 20 Jun 1997 | K971774 | NSK PUSH-BUTTON MIDWEST REPLACEMENT TURBINE:FOR QUIETAIR AND TRADITION | Nsk Nakanishi, Inc. |
| 6 May 1997 | K970104 | SANI-SHIELD | Dw Industries, Inc. |
| 31 Mar 1997 | K963843 | ELECTRIC SURGICAL IRRIGATION SYSTEM - DUAL CONTROLLER UNIT | Micro Motors, Inc. |
| 17 Jan 1997 | K961275 | SIRIUS 10, 10L, 40, 40L | Micro-Mega Societe Anonyme |
| 8 Jan 1997 | K961235 | SIRIUS 180, 180L, 230, 230L | Micro-Mega Societe Anonyme |
| 24 Oct 1996 | K963664 | DENTAL HANDPIECE AND ACCESSORY | Filmtech |
| 18 Oct 1996 | K962877 | MIDWEST 300 SE | Midwest Dental Products Corp. |
| 11 Oct 1996 | K963050 | TRADITION P, PUSH BUTTON HANDPIECE | Midwest Dental Products Corp. |
| 24 Sep 1996 | K962542 | AIR MOTOR HANDPIECE TN-102 | Nsk Nakanishi, Inc. |
| 11 Sep 1996 | K962543 | ALPHA AIR HANDPIECE, ULTRA-PUSH, AL-SU, AL-MU, AL-TU | Nsk Nakanishi, Inc. |
| 6 Aug 1996 | K952927 | IMPACT AIR 45 4-HOLE | Palisades Pharmaceutics, Inc. |
| 26 Apr 1996 | K961076 | MM 324 | Micro-Mega Societe Anonyme |
| 23 Apr 1996 | K961163 | LARES RESEARCH AS-1 LOWSPEED HANDPIECE | Lares Research |
| 28 Mar 1996 | K960541 | LYNX DPA DISPOSABLE PROPHY ANGLE | CNC Manufacturing, Inc. |
| 5 Mar 1996 | K955655 | MIDWEST ONE | Midwest Dental Products Corp. |
| 21 Feb 1996 | K960352 | ALLRAP/SLIP-N-GRIP | Dental Disposables Intl., Inc. |
| 8 Feb 1996 | K955654 | SHORTSTOP DISPOSABLE PROPHY ANGLE | Spintech, Inc. |
| 29 Jan 1996 | K945256 | MTC 7707 HIGH SPEED AIR TURBINE | Mtc Industries and Research, Ltd. |
| 16 Jan 1996 | K954722 | MICRO-DISPENSER 7000 & MICRODISPENSER 8000 | Nouvag AG |
| 4 Jan 1996 | K954991 | PHASE CHANGE DENTAL LUBRICANT | Phase Change |
| 8 Nov 1995 | K954012 | DISPOSABLE PROPHY HANDPIECE | Denticator Intl., Inc. |
| 5 Oct 1995 | K945734 | W&H ROTO QUICK COUPLINGS | A-dec, Inc. |
| 5 Oct 1995 | K944719 | W&H 100 SERIES LOW SPEED | A-dec, Inc. |
| 5 Oct 1995 | K944718 | W&H 900 INCOLIGHT LT HANDPIECE | A-dec, Inc. |
| 28 Aug 1995 | K944713 | W&H MICRO AIR MOTOR LT25 | A-dec, Inc. |
| 25 Aug 1995 | K944714 | W&H CORSAIR SCALER | A-dec, Inc. |
| 25 Aug 1995 | K944712 | W&H MICRO MOTOR E25 (WITHOUT LIGHT) | A-dec, Inc. |
| 25 Aug 1995 | K944711 | W&H AIR MOTOR A25 | A-dec, Inc. |
| 15 Aug 1995 | K932333 | PROTECTORAL ULTRASONIC HANDPIECE PROCESSOR | Gull Laboratories, Inc. |
| 8 Jun 1995 | K944709 | W&H 896 TOP LIGH HIGHSPEED | A-dec, Inc. |
| 2 Jun 1995 | K944717 | W&H 798 TOP AIR TURBINE TRIPLE SPRAY | A-dec, Inc. |
| 2 Jun 1995 | K944716 | W&H 796 TOP AIR TURBINE MINI-HEAD | A-dec, Inc. |
| 2 Jun 1995 | K944715 | W&H 795 TOP AIR TURBINE SINGLE SPRAY | A-dec, Inc. |
Showing the 200 most recent of 263.
Official records: FDA product classification for EFB · 21 CFR 872.4200.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026