Dental handpieces: manufacturers and brands
98 companies make or specify dental handpieces among the 164 that list one with FDA, under 2,095 brand and model names. FDA has issued 451 510(k) clearances in this category, 46 of them in the last five years.
510(k) clearances per year, 1976–2026
Dental handpiece manufacturers
Makers first, then the most recently active. “Maker” means the company manufactures the device or owns its specifications; a “lister” repacks, relabels, imports or distributes it.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Institut Straumann AG | Switzerland | Maker | CONTRE-ANGLES · HAND-PIECES · IMPULSION CONTRA-ANGLES · MONT BLANC IMPLANTOLOGY · +3 | 212 | 2026 |
| Dentsply Sirona, Inc. | United States | Maker | Midwest E mini · Midwest Rhino XP · Midwest Shorty Single Speed Air Motor · Midwest Shorty Two Speed Air Motor · +8 | 148 | 2026 |
| Dentis Co., Ltd. | South Korea | Maker | ChecQ (AC100) | 37 | 2026 |
| Nakanishi, Inc. | Japan | Maker | A450L · AB450L SU · AIR MOTOR HANDPIECE TN-102 · AK400L · +430 | 37 | 2026 |
| Nobel Biocare Services AG | Switzerland | Maker | Handpiece S-11, straight 1:1 · CA · Beacon · Smart Pegs Type 1-115 | 94 | 2026 |
| Guilin Woodpecker Medical Instrument Co., Ltd. | China | Maker | ACE · Cordless Prophy System · E-COM, Endo Radar · Endo Motor, Ai- Motor, Endo Radar Plus · +24 | 12 | 2025 |
| Sybron Dental Specialties | United States | Maker | elements Connect · elements motor · EndoTouch TC2 · M4 TC2 Handpiece · +5 | 203 | 2026 |
| GENOSS Co., Ltd. | South Korea | Maker | TT-1 | 23 | 2025 |
| Foshan COXO Medical Instrument Co., Ltd. | China | Maker | Air Motors; CX235-3B, CX235-3C, CX235-3F · Dental Electrical Motors; C-PUMA MASTER · Dental Implantation Systems; C-Sailor Pro · Geared Angle Handpieces; CX235-1B, CX235-1C, CX235-1F, CX235-1G, CX235C1, CX235C2, CX235C3 · +5 | 6 | 2025 |
| Inter-Med, Inc. | United States | Maker | Impact Air 45 | 7 | 2026 |
| Dent4You AG | Switzerland | Maker | STATCARE Handpiece Spray · STATMATIC Spray | 5 | 2026 |
| Meta Biomed Co, Ltd | United States | Maker | EQ-M | 24 | 2024 |
| MICRO-NX Co., Ltd. | South Korea | Maker | Dental Handpiece, Wireless Endodontic Handpiece, endoit (Model: EH-C500) · Dental Torque Driver for Implant Surgery (Model: MEG-TORQ) · Dental Torque Driver for Implant Surgery (Model: OSM-TORQ) · Dental Torque Driver for Implant Surgery (Model: TD-C60) · +9 | 7 | 2025 |
| Premier Dental Products Company | United States | Maker | AeroPro Cordless Prophy System | 28 | 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 · +10 | 23 | 2025 |
| Saeshin Precision Co., Ltd. | South Korea | Maker | ACL(B)-61I, ACL(B)-62I, ACL(B)-63I, ACL(B)-65I, ACL(B)-04C · AHP-85-SS · DENTIS DIP20 · MEARA; MEAHP · +7 | 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 |
| Changzhou Sifary Medical Technology Co., Ltd. | China | Maker | E-Connect S Endo Motor With Built-In Apex Locator · Z-Evo | 4 | 2026 |
| Satelec - Acteon Group | United States | Maker | Air-N-Go by Satelec Air-N-Go Easy by Satelec · handpiece Air Powered Dental · EndoCenter · I-SURGE + · +1 | 18 | 2024 |
| Dentalez, Inc. | United States | Maker | Concentrix MX Handpiece - 265630 · DentaLube II - 262539 · HiFlo Fiber Optic Swivel · LED Plug N Play Swivel Assembly · +47 | 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 · +69 | 8 | 2022 |
| Handpiece Headquarters | United States | Maker | Dental Handpiece Cleaner and Lubricant · DHR · HHC · Medidenta Air King · +12 | 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 · +19 | 6 | 2023 |
| Pac-Dent Inc. | United States | Maker | ACCLEAN ERGO PROPHY ANGLE LF · AntiSplatr Disposable Prophy Angles · AntiSplatr Flex Ergo Slim Disposable Prophy Angle Bulk Pack, Contra Angle, Flex Cup, 1,200ct · AntiSplatr Flex Ergo Slim Disposable Prophy Angle, Contra Angle, Flex Cup, 200ct · +9 | 5 | 2022 |
| Perimetrics, Inc | United States | Maker | InnerView System | 3 | 2025 |
| Premium Plus (Dongguan) Limited | China | Maker | Disposable Prophy Angles | 2 | 2025 |
| 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 |
| Coltene/Whaledent AG | Switzerland | Maker | CanalPro CL · CanalPro CL2 · CanalPro X-Move · K-Spray Handpiece Spray · +2 | 45 | 2022 |
| Osteomed, LLC | United States | Maker | — | 26 | 2022 |
| W&H Dentalwerk Buermoos GmbH | Austria | Maker | — | 17 | 2026 |
| Essential Dental Systems, Inc. | United States | Maker | Endo-Express · Endo CSV Hand Piece | 15 | 2023 |
| Osstell AB | Sweden | Maker | Mega ISQ II · NeoTell · Osstell Beacon · Osstell Classic · +24 | 5 | 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, · +2 | 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. · +132 | 2 | 2021 |
| ChangZhou BoMedent Medical Technology Co., Ltd | China | Maker | Dental Electrical Motor iRoot Pro | 2 | 2022 |
| Shenzhen Rogin Medical Co., Ltd. | China | Maker | Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO) | 1 | 2025 |
| Shenzhen Superline Technology Co Ltd | China | Maker | Endo Handpiece, Endo Motor,Dental handpiece, Fliex | 1 | 2025 |
| 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 |
| Denjoy Dental Co., Ltd. | China | Maker | Integrated Endo System (Meet Endo-II) · JAS Activator · JAS Activator Ultrasonic Tips · JAS Charging Unit · +7 | 1 | 2025 |
| Pacific Care Limited | Hong Kong SAR China | Maker | Disposable Prophy Angle | 1 | 2025 |
| Shenzhen Perfect Medical Instruments Co., Ltd. | China | Maker | Endo Motor | 1 | 2023 |
| Forum Engineering Technologies (96) Ltd. | Israel | Maker | EM-07 Cordless Endo Motor · Statera vi · X-Smart Go | 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 |
| Aseptico, Inc. | United States | Maker | AE-10 - TUBING LRG 5FT/MIN FOR AE-20 SILICONE 62ID X .125OD · AE-2 - FTN BARB 1/16 Y PLASTIC · AE-20 - TUBING PUMP SET ASEPTICO · AE-20Y - TUBING PUMP SET AEU-707Y YOSHIDA · +181 | 17 | 2015 |
| Bonart Co., Ltd. | Taiwan | Maker | Bonart (ART) Dental Handpieces, Disposable Prophy Angle (PROFORMANCE) & Accessories | 14 | 2017 |
| Monitex Industrial Co., Ltd. | Taiwan | Maker | HPR Cordless Hygiene Handpiece | 9 | 2017 |
| 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 |
| Asi Medical, Inc. | United States | Maker | Advanced Dental System · Advanced Endodontic System · Triton Dental System | 5 | 2013 |
| 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 |
| Nouvag AG | Switzerland | Maker | Clip for external cooling · Clip for internal cooling · Contra angle · Handpiece · +1 | 4 | 2008 |
| Premium Plus International Limited | Hong Kong SAR China | Maker | Premium Plus · Pro-Sys Hygiene Handpiece · Prophy Air Motor · 1002-4 · +3 | 3 | 2017 |
| Preventive Technologies, Inc. | United States | Maker | ESA® mate slow speed air driven motor · ESA EXTENDED STRAIGHT | 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 |
| Osada Electric Co., Ltd. | Japan | Maker | OSADA HANDPIECE, DIRECT DRIVE, AC-POWERED | 2 | 1994 |
| Angstrom Mfg., Inc. | United States | Maker | Prophy Angle | 2 | 2011 |
| Dpm USA Corp. | United States | Maker | Tubinetta Fit Lux, Tubinetta Ultra, Switch E, Bogotta Light Plus, Bogota Stilla Prime | 2 | 2009 |
| 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 · EndoPilot² · +1 | 1 | 2007 |
| Nakamura Dental Handpiece Mfg. Co., Ltd. | Japan | Maker | ACCLEAN · CONTRA ANGLE · HyGenie · ND · +5 | 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 |
| DMS Co., Ltd. | South Korea | Maker | AnyCheck IMT-100 | 1 | 2019 |
| Schlumbohm GmbH & Co. KG | Germany | Maker | EndoPilot | 1 | 2021 |
| Filmtech | United States | Maker | BRIXTON | 1 | 1996 |
| Microtech | United States | Maker | Dentex | 1 | 2002 |
| SPS/Crosstex International | United States | Maker | TWIST RECIPROCATING D · Sparkle EZ Contra Angle · Sparkle Prophy Angle · Twist Plus | — | — |
| Dentatus AB | Sweden | Maker | Profin/EVA · Profinet | — | — |
| 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 · +1 | — | — |
| Solventum US LLC | United States | Maker | — | — | — |
| J. Morita MFG Corp. | Japan | Maker | Air Solfy · AIR TORX · ARETE Handpiece Maintenance Unit · LUBRICARE · +17 | — | — |
| AMD Medicom Inc | Canada | Maker | Medicom Prophy Angle · Prophy Angle | — | — |
| Onvet Medical Canada Inc. | Canada | Maker | AMW AirPeak G100, G200, G200X;G300, G400,MT05;MT20; P100; AMW iTesla G500, G600, G700, G800,MT40 · iTesla Dental Implant System · Endo Motors | — | — |
| LM-Instruments Oy | Finland | Maker | — | — | — |
| Sanko Electronics Corporation | Japan | Maker | EMD120V1 · EMD120VS · iProphy mobile complete set · iProphy mobile Motor · +1 | — | — |
| SycoTec GmbH & Co KG | Germany | Maker | Midwest Plus Automate Spray · Midwest® 6-pin Coupler, K-style CE · STATIS, ML and SL · STATMATIC 31 · +8 | — | — |
| EMS Electro Medical Systems SA | Switzerland | Maker | AIR-FLOW HANDY 2+ · AIR-FLOW HANDY 3 · AIR-FLOW HANDY 3 PERIO · PERIO-FLOW NOZZLE | — | — |
| Cordica Medical (Formally Team Technologies, Inc) | United States | Maker | — | — | — |
| Integration Diagnostics Sweden AB | Sweden | Maker | IS3 · IS4 · Locking screwdriver · MDI MulTipeg · +7 | — | — |
| Dhef Inc. | Taiwan | Maker | — | — | — |
| Tani Electronics Corporation | Japan | Maker | FC-78 · Surgic Pro NON-OPT(120V) · Surgic Pro OPT(120V) · Surgic Pro OPT(230V) · +1 | — | — |
| SAEYANG Co.,Ltd 韩国（株）世洋 | South Korea | Maker | CanalPro CL2 · Endo A Class · PRO M CLASS | — | — |
| Sinol Dental Limited | China | Maker | Dental Low Spped Handpiece includin · High Speed Air Turbine Handpiece Se | — | — |
| Force Engineering Co.ltd | Japan | Maker | EM13M | — | — |
| Jung Chen Technology Co., Ltd | China | Maker | AeroPro Cordless Prophy System | — | — |
| Petoskey Plastics | United States | Maker | Dental Chair Cover non sterile | — | — |
| Integrated Solutions, Inc. | United States | Maker | BioLube | — | — |
| Nextmed srls | Italy | Maker | EnDrive | — | — |
| Proguard Health Inc. | United States | Maker | — | — | — |
| TUNAP GmbH & Co. KG | Germany | Maker | — | — | — |
| Prismatik Dentalcraft, Inc. | United States | Contract manufacturer | — | 56 | 2026 |
| Shofu Inc | Japan | Contract manufacturer | LAB AIR Z HANDPIECE | 96 | 2025 |
| Hiossen Inc. | United States | Manufacturer | SM3 | 26 | 2026 |
| Ultradent Products, Inc. | United States | Contract manufacturer | Ultrapro Tx Air Hygiene Handpiece · Ultrapro TX Air Motor and Nose Cones · Ultrapro Tx Cordless Prophy Motor Kit | 95 | 2026 |
| Paltop Advanced Dental Solutions Inc. | United States | Contract manufacturer | Contra Angle NSK | 7 | 2025 |
| Park Dental Research Corp | United States | Contract manufacturer | — | 8 | 2026 |
| Imagine Milling Technologies, LLC | United States | Contract manufacturer | Penguin RFA MulTipegs | 4 | 2026 |
| Neobiotech Co., Ltd. | South Korea | Foreign exporter | AnyCheck IMT-100 | 17 | 2024 |
| SIC invent AG | Switzerland | Foreign exporter | — | 5 | 2026 |
| Keystone Industries | United States | Contract manufacturer | Prophybrite Air Polishing Unit · Fortis Disposable Prophy Angles · Keystone Disposable Prophy Angles · Nero Disposable Prophy Angles | 2 | 2025 |
| A-dec, Inc. | United States | Manufacturer | Air High Speed Handpieces · Air Low Speed Handpiece · Alegra · AM-20 MW · +18 | 68 | 2022 |
| DIO Corporation | South Korea | Foreign exporter | DIO IDx | 14 | 2023 |
| Neoss AB | Sweden | Foreign exporter | — | 10 | 2022 |
| NuSmile, Ltd. | United States | Manufacturer | Avalon Biomed by ZARC Z-Evo | 2 | 2026 |
| 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 · +49 | 1 | 2025 |
| Setagaya Seiki Co., Ltd. | Japan | Foreign exporter | — | 1 | 2026 |
| Bicon, LLC | United States | Manufacturer | Impulsion · WI-75 E/KM · AEU-26BIC | 18 | 2015 |
| SWEDEN & MARTINA S.p.A. | Italy | Contract manufacturer | DENTAL HANDPIECE | 6 | 2019 |
| Dentamerica | United States | Repacker / relabeler | — | 4 | 2010 |
| Tpc Advanced Technology, Inc. | United States | Repacker / relabeler | TPC Air Driven Dental Drill | 3 | 2007 |
| Integra LifeSciences Corporation | United States | Contract manufacturer | Miltex · Padgett · Tardie | 2 | 2014 |
| COLTENE Holding AG | Switzerland | Contract manufacturer | CanalPro X-Move | 1 | 2003 |
| 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 | — | — |
| Sweden & Martina INC | United States | Lister | IMPLANT ANGLE HANDPIECE · MICRONITI ROTARY ENDOHANDPIECE · DENTAL HANDPIECE | — | — |
| 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 · Dental Electric Motor · Dental Electric Motor / Dental Implantation System · JMU Dental High-speed Turbine Handpiece · +2 | — | — |
| 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 · +12 | — | — |
| Swann Morton Limited | United Kingdom | Contract sterilizer | 100350 SmartPeg Type 4 · 100353 SmartPeg Type 1 · 100355 SmartPeg Type 2 · 100357 SmartPeg Type 3 · +101 | — | — |
| Soher Med Limited | Hong Kong SAR China | Foreign exporter | dental lubricant | — | — |
| STERIS Corporation | United States | Contract sterilizer | — | — | — |
| HSG-S Corp | United States | Manufacturer | EdgeApex · EdgeApex HP · EdgeEndo® · EdgeFlow | — | — |
| Samtrade Supplies Inc. | Canada | Foreign exporter | Kavo Spray | — | — |
| Nordent MFG., Inc. | United States | Contract manufacturer | AP-H, AP-H Plus · MT-2 · MOTOPEX | — | — |
| GoldenDent | United States | Repacker / relabeler | Dental Air Polishing Handpiece · Dental Electric Motor, MT2, MT3, Controller Foot, Handpience and Cord, Contra and Right Angle attachment · Endo Motor | — | — |
| 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 | — | — |
| Zarc4Endo S.A. | Spain | Private-label distributor | Z-EVO | — | — |
| CARGUS International Inc. | United States | Repacker / relabeler | — | — | — |
| W.H. Holden Inc. DBA H & H Company | United States | Contract manufacturer | — | — | — |
| Jiangsu Yabaobao Medical Instrument Co.,Ltd. | China | Foreign exporter | — | — | — |
| Medline Industries, LP | United States | Contract sterilizer | — | — | — |
| Maxill Inc. | United States | Foreign exporter | Maxill | — | — |
| Ads Dental System Inc. | United States | Remanufacturer | AP-H; AP-H Plus · Contra-angle handpiece: WJ-45L, WJ-45TL;Dental Electric Motor:MT2,M2 Pro · Motopex | — | — |
| Toyo Medical Co. | United States | Repacker / relabeler | nakanishi · TOYO MEDICAL CO · Nakanishi Inc | — | — |
| HANSAMED LIMITED dba CITAGENIX | Canada | Foreign exporter | Penguin RFA | — | — |
| ATOMO Dental, Inc. | United States | Repacker / relabeler | PROPHY ANGLE | — | — |
| 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 · Handpiece | — | — |
| Sanicure BV | Netherlands | Foreign exporter | Handpiece, contra- and right-angle attachment, dental · Handpiece, air-powered, dental | — | — |
| Zapalign LLC | United States | Repacker / relabeler | Handpiece, air-powered, dental · Handpiece, contra- and right-angle attachment, dental | — | — |
| Peter Brasseler Holdings, LLC | United States | Contract manufacturer | Brasseler Electric Motor · Brasseler Forza Attachments · Forza + | — | — |
| Zapalign Inc. | South Korea | Foreign exporter | — | — | — |
| Enova Illumination Inc. | United States | Lister | Endo Motor | — | — |
| Head Dental Corp. | United States | Repacker / relabeler | Handpiece, air-powered, dental | — | — |
| Nouvatec LLC | United States | Repacker / relabeler | Nouvag AG | — | — |
| Well Medical | South Korea | Foreign exporter | AUTOTORQ-35 | — | — |
| 3D Dental Designs and Development LLC | United States | Contract manufacturer | — | — | — |
| Boone Center, Inc. | United States | Repacker / relabeler | — | — | — |
| Mainline Medical Dental Supply | Canada | Foreign exporter | — | — | — |
| Oketz Logistics LLC | United States | Repacker / relabeler | — | — | — |
| Riverside Medical Packaging Company Ltd | United Kingdom | Repacker / relabeler | — | — | — |
| Swedent Dental Wholesale Group | United States | Repacker / relabeler | — | — | — |
| Worldwide Supplies Limited | Hong Kong SAR China | Foreign exporter | — | — | — |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Where dental handpieces are made
Number of makers in this category with a manufacturing establishment in the country.
FDA device types in this category
| Device type | Class | Regulation | Makers | Clearances |
|---|---|---|---|---|
| Dental Air-Powered HandpieceEFB | 1 | 872.4200 | 54 | 263 |
| Dental Contra- and Right-Angle Attachment HandpieceEGS | 1 | 872.4200 | 44 | 73 |
| Ac-Powered Direct Drive HandpieceEKX | 1 | 872.4200 | 41 | 90 |
| Dental Belt and/or Gear Driven HandpieceEFA | 1 | 872.4200 | 9 | 25 |
Recent clearances
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 1 Oct 2026 | K260029 | Firstar Dental Handpieces | Firstar Dental Company | EFB Dental Air-Powered Handpiece |
| 23 Sep 2026 | K262144 | DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor Handpiece | Setagaya Seiki Co., Ltd. | EFB Dental Air-Powered Handpiece |
| 8 Sep 2026 | K261987 | Reusable SmartPeg | Osstell AB | EKX Ac-Powered Direct Drive Handpiece |
| 12 Jan 2026 | K251389 | High speed air turbine handpiece | Foshan Topmed Dental Co., Ltd. | EFB Dental Air-Powered Handpiece |
| 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. | EFB Dental Air-Powered Handpiece |
| 16 Oct 2025 | K252223 | Alpha Endo Handpiece (Alpha Endo) | Shenzhen Superline Technology Co Ltd | EKX Ac-Powered Direct Drive Handpiece |
| 18 Sep 2025 | K251597 | InnerView System | Perimetrics, Inc | EKX Ac-Powered Direct Drive Handpiece |
| 15 Sep 2025 | K251869 | Disposable Prophy Angle (3399-60, 3399-090, 3399-105) | Premium Plus (Dongguan) Limited | EGS Dental Contra- and Right-Angle Attachment Handpiece |
| 22 Aug 2025 | K243692 | EnDrive (EnDriveUS) | Advanced Technology Research (A.T.R.) S.R.L. | EKX Ac-Powered Direct Drive Handpiece |
| 28 May 2025 | K240950 | Disposable Prophy Angle | Pacific Care Limited | EGS Dental Contra- and Right-Angle Attachment Handpiece |
| 24 Apr 2025 | K242514 | Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO) | Shenzhen Rogin Medical Co., Ltd. | EKX Ac-Powered Direct Drive Handpiece |
| 21 Mar 2025 | K241065 | ChecQ (AC100) | Dentis Co., Ltd. | EKX Ac-Powered Direct Drive Handpiece |
| 28 Feb 2025 | K242179 | Synea Fusion Handpieces (Intensiv & Profin) | W&H Dentalwerk Bürmoos GmbH | EFB Dental Air-Powered Handpiece |
| 20 Dec 2024 | K243911 | HPR Cordless Hygiene Handpiece | Handpiece Headquarters | EKX Ac-Powered Direct Drive Handpiece |
| 13 Nov 2024 | K240337 | Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L) | Guangdong JINME Medical Technology Co., Ltd. | EFB Dental Air-Powered Handpiece |
| 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. | EFB Dental Air-Powered Handpiece |
| 20 Sep 2024 | K241880 | Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing System (Perio Mate Nozzle Tip) | Nakanishi, Inc. | EFB Dental Air-Powered Handpiece |
| 19 Sep 2024 | K240183 | Star E900 Handpiece Series | Dentalez, Inc. | EGS Dental Contra- and Right-Angle Attachment Handpiece |
| 9 Aug 2024 | K222688 | The Trust | GENOSS Co., Ltd. | EKX Ac-Powered Direct Drive Handpiece |
| 24 Jul 2024 | K233865 | X-Smart Pro; X-Smart Pro+ | Dentsply Sirona, Inc. | EKX Ac-Powered Direct Drive Handpiece |
| 9 Jul 2024 | K232551 | EM-07 Cordless Endo Motor | Forum Engineering Technologies (96) Ltd. | EKX Ac-Powered Direct Drive Handpiece |
| 30 Apr 2024 | K233122 | High Speed Air Turbine Handpiece (G100,G200,G300,G400,G450,G500,G600,G700,G700L,G800,G800L) | Litu Tech Ltd. | EFB Dental Air-Powered Handpiece |
| 25 Apr 2024 | K233308 | Air Motor (Model name: FX204 M4); Air Motor (Model name: M205) | Nakanishi, Inc. | EFB Dental Air-Powered Handpiece |
| 9 Nov 2023 | K232810 | Dental Handpiece, Wireless Endodontic Handpiece, endoit | MICRO-NX Co., Ltd. | EKX Ac-Powered Direct Drive Handpiece |
| 22 Sep 2023 | K220179 | High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air Motors | Foshan COXO Medical Instrument Co., Ltd. | EFB Dental Air-Powered Handpiece |
| 1 Sep 2023 | K232657 | InnerView LC | Perimetrics, Inc | EKX Ac-Powered Direct Drive Handpiece |
| 23 Aug 2023 | K232243 | EVO 700 series high speed handpiece | Ttbio Corp. | EFB Dental Air-Powered Handpiece |
| 2 Jun 2023 | K230888 | Titanium Turbine | Nakanishi, Inc. | EFB Dental Air-Powered Handpiece |
| 24 May 2023 | K230106 | General Cutting Straight | Nakanishi, Inc. | EGS Dental Contra- and Right-Angle Attachment Handpiece |
| 18 May 2023 | K220829 | Endo Motor | Foshan COXO Medical Instrument Co., Ltd. | EKX Ac-Powered Direct Drive Handpiece |
| 26 Apr 2023 | K222548 | Endo Motor | Shenzhen Perfect Medical Instruments Co., Ltd. | EKX Ac-Powered Direct Drive Handpiece |
| 22 Feb 2023 | K221741 | TRAUS Air Dental Handpiece | Saeshin Precision Co., Ltd. | EFB Dental Air-Powered Handpiece |
| 12 Dec 2022 | K202674 | Medidenta High Speed Handpieces | Pac-Dent Inc. | EFB Dental Air-Powered Handpiece |
| 17 Nov 2022 | K212910 | Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece | Shenzhen Carejoy Technology Co., Ltd. | EFB Dental Air-Powered Handpiece |
| 17 Nov 2022 | K222518 | FX Contra | Nakanishi, Inc. | EGS Dental Contra- and Right-Angle Attachment Handpiece |
| 7 Nov 2022 | K220874 | Smooth Drive contra angle and straight handpieces | Lares Research | EGS Dental Contra- and Right-Angle Attachment Handpiece |
| 7 Nov 2022 | K220346 | Lotus Prophy Angle | Ajk Engineering, Inc. | EGS Dental Contra- and Right-Angle Attachment Handpiece |
| 28 Sep 2022 | K221548 | Dental Air Polishing Handpiece | Guilin Woodpecker Medical Instrument Co., Ltd. | EFB Dental Air-Powered Handpiece |
| 21 Sep 2022 | K210475 | EQ-M | Meta Systems Co., Ltd. | EKX Ac-Powered Direct Drive Handpiece |
| 19 Sep 2022 | K213897 | Pro M Class | Saeyang Microtech Co., Ltd. | EKX Ac-Powered Direct Drive Handpiece |