Atlas FDA

EFB

261 FDA 510(k) clearances · Product code

104 daysmedian time to decision
339 days90th percentile
261clearances measured

FDA profile

Official device name
Handpiece, Air-Powered, Dental
Device class
Class I (low risk)
Regulation
21 CFR 872.4200
Medical specialty
Dental
Flags
Third-party review eligible
Adverse events (MAUDE)
2021: 123 · 2022: 157 · 2023: 116 · 2024: 104 · 2025: 83 · 2026: 80
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
High speed air turbine handpiece (K251389)Foshan Topmed Dental Co., Ltd.2026-01-12
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) (K251388)Foshan Topmed Dental Co., Ltd.2026-01-12
Synea Fusion Handpieces (Intensiv & Profin) (K242179)W&H Dentalwerk Bürmoos GmbH2025-02-28
Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L) (K240337)Guangdong Jinme Medical Technology Co., Ltd.2024-11-13
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) (K241074)Foshan Soco Precision Instrument Co., Ltd.2024-11-12
Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing System (Perio Mate Nozzle Tip) (K241880)Nakanishi, Inc.2024-09-20
High Speed Air Turbine Handpiece (G100,G200,G300,G400,G450,G500,G600,G700,G700L,G800,G800L) (K233122)Litu Tech , Ltd.2024-04-30
Air Motor (Model name: FX204 M4); Air Motor (Model name: M205) (K233308)Nakanishi, Inc.2024-04-25
High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air Motors (K220179)Foshan Coxo Medical Instrument Co., Ltd.2023-09-22
EVO 700 series high speed handpiece (K232243)Ttbio Corp.2023-08-23
Titanium Turbine (K230888)Nakanishi, Inc.2023-06-02
TRAUS Air Dental Handpiece (K221741)Saeshin Precision Co., Ltd.2023-02-22
Medidenta High Speed Handpieces (K202674)Pac-Dent, Inc.2022-12-12
Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece (K212910)Shenzhen Carejoy Technology Co., Ltd.2022-11-17
Dental Air Polishing Handpiece (K221548)Guilin Woodpecker Medical Instrument Co., Ltd.2022-09-28
OK Handpiece (K221814)Jaintek Co.,Ltd2022-07-15
Stainless Turbine (K203791)Nakanishi, Inc.2022-06-21
Highspeed Airturbine Handpiece (K202371)Beijing Dongbo Dental Handpiece Co., Ltd.2021-11-08
Dental Low-speed Handpieces and Accessories (K202786)Microp Technology (Taiwan), Inc.2021-09-03
Disposable High Speed Air Turbine Handpiece (K193264)Ningbo Hpdove Dental Instruments Co., Ltd.2020-08-11
High-speed air turbine handpiece / Low-speed air turbine handpiece (K181691)Foshan Wenjian Medical Instrument Co., Ltd.2020-05-26
Lubrina 2 (K190509)J. Morita USA, Inc.2020-03-04
Midwest Rhino XE and Air Motor M (K192409)Dentsply Sirona2020-01-13
SD500 Elite LubeFree High Speed Handpiece, SD500 Elite Lubricated High Speed Handpiece, SD500 Pro LubeFree High Speed Handpiece, Pro Lubricated High Speed Handpiece (K192412)Dentalez, Inc.2020-01-06
EVO 450 series High Speed Handpieces (K190508)Ttbio Corp.2019-12-11
Dental high speed handpiece, Dental low speed handpiece (K181900)Foshan Cicada Dental Instrument Co, Ltd.2019-12-09
PROPHYflex 4 (K181110)Kaltenbach & Voigt GmbH2019-04-10
Dental High-speed Handpiece and Accessories (K173943)Microp Technology (Taiwan), Inc.2018-07-24
High-speed Turbine Handpieces for Single Use (K172543)Beijing Dongbo Dental Handpiece Co., Ltd.2018-07-11
Concentrix MX-AC High-Speed Handpiece (K173465)Dentalez, Inc.2018-03-28
PERIO-FLOW nozzle (K171174)E.M.S Electro Medical Systems S.A2017-12-18
W&H Assistina Twin (K171553)W&H Dentalwerk Buermoos GmbH2017-12-08
Dental Low-speed Turbine Handpiece (K170236)Guangdong Jinme Medical Technology Co., Ltd.2017-11-21
Dental High-speed Turbine Handpiece (K170229)Guangdong Jinme Medical Technology Co., Ltd.2017-11-08
Premium Plus Prophy Air Motor (K170261)Premium Plus International Limited2017-10-19
PANA SPRAY Plus (K163483)Nakanishi, Inc.2017-08-15
Air-Powered Handpieces and Handpiece Attachments (K162926)W&H Dentalwerk Burmoos GmbH2017-02-23
WOlf High Speed Handpieces - Medium head, WOlf High Speed Handpieces - Small head (K160410)Dental Savings Club2016-09-29
430 Torque High-Speed Handpiece Series - 430 SWL Torque High Speed Handpiece, 430 SW Torque High Speed Handpiece (K153411)Dentalez, Inc.2016-04-08
AIR-FLOW handy 3.0 PLUS (K151912)E.M.S Electro Medical Systems S.A2016-02-03
High Speed Handpieces and Accessories (K152146)Codent Technical Industry Co., Ltd.2015-12-08
Advanced Air System (K143704)W&H Dentalwerk Buermoos GmbH2015-11-23
MDK HANDPIECES (K141886)Modern Korea Co., Ltd.2015-05-13
Maxima PRO 45L (K141576)Kavo DO Brasil Industria E Comercio Ltda2015-05-04
Codent Low Speed Dental Handpieces and Accessories (K150798)Codent Technical Industry Co., Ltd.2015-04-24
EVO 500 SERIES HIGH SPEED HANDPIECES/TIGER 500/300/101 SERIES HIGH SPEED HANDPIECES (K141183)Ttbio Corp.2015-02-27
Maxima XTEND Handpiece Maintenance System (K143183)Handpiece Headquarters2015-02-17
LARES ULTRALITE PROSTYLE HIGH-SPEED DENTAL HANDPIECES, LARES EURO PROSTYLE HIGH-SPEED DENTAL HANDPIECES, LARES TURBO+ PR (K141221)Lares Research, Inc.2014-10-28
#8C RENEGADE DENTAL HANDPIECE (K142063)Handpiece Club, LLC2014-10-28
CODENT LOW SPEED DENTAL HANDPIECES AND ACCESSORIES (K133069)Codent Technical Industry Co., Ltd.2014-10-24
T1/T2/T3 TURBINE FAMILY (K131319)Sirona Dental Systems GmbH2014-05-30
AIR-FLOW HANDY 3.0 (K132478)E.M.S Electro Medical Systems S.A2014-04-11
QUICK JET M (K133170)Micron Corp.2014-03-28
AIR-FLOW HANDY 3.0 PERIO (K132480)E.M.S Electro Medical Systems S.A2014-02-24
MASTERTORQUE LUX 8900 L (K130560)Kaltenbach & Voigt GmbH2013-09-27
430 SWL 45 AND 430 SW 45 HIGH-SPEED HANDPIECES (K130455)Dentalez Group, Stardental Division2013-09-25
PANA SPRAY PLUS (K131014)Nsk America Corp.2013-08-12
TEK USA E-GENERATOR INTEGRATED LED HANDPIECE (HIGH & LOW SPEED AIR TURBNINE DENTAL HANDPIECE) (K120218)Palm Beach Dental Supply D/B/A Tek USA2012-06-29
TI-MAX X450 (K112024)Nakanishi, Inc.2012-06-20
SPRAY & CLEAN HANDPIECE CLEANER& LUBRICANT MAXIMA HANDPIECE CLEANER & LUBRICANT EZCARE HANDPIECE CLEANER & LUBRICANT (K113674)Handpiece Headquarters, Inc. - Hpr, Inc.2012-04-05
TI-MAX X TURBINE (K113655)Nakanishi, Inc.2012-03-05
ND LOWSPEED AIRMOTOR,ND HIGHSPEED AIRTURBINE HANDPIECE (K113222)Nakamura Dental Handpiece Mfg. Co., Ltd.2012-02-23
ORTHOSLENDERIZER (K111249)Orthomatics, Inc.2012-02-08
PROPHY-MATE NEO (K112673)Nakanishi, Inc.2012-02-07
CONCENPIECE,HIGH-SPEED HANDPIECE SERIES (K113301)Dentalez, Inc.2012-01-23
EASYPROPHY SERIES AIR POLISH DEVICES, MODELS EASYPROPHY 200 AND EASYPROPHY 400 (K112869)Beyes Dental Canada, Inc.2011-12-16
AIRLIGHT DENTAL HANDPIECE (K112623)Beyes Dental Canada, Inc.2011-12-16
AIR-N-GO (K110379)Satelec2011-12-08
TIGER 500 SERIES HIGH SPEED HANDPIECES AND ATTACHMENTS (K102517)Thunder Tiger Corp.2011-04-27
BOSWORTH AIR POLISHER (K100731)Harry J. Bosworth Co.2010-12-03
PACEMAKER HIGH-SPEED HANDPIECE MODEL PM-MQ, PM-M (K101551)Delma Medical Instrument (Guangzhou) Co., Ltd.2010-09-09
DENTAL HANDPIECES, MODELS: KARAM STD/MINI; BREEZE STD/MINI: KARAM 45; DEXOR 45; KARAM 4H COUPLING (K101717)Aerobine, Inc.2010-08-20
HHC PUSH-BUTTON REPLACEMENT TURBINE FOR MIDWEST TRADITION HANDPIECE MODEL MW TURBINE REPLACEMENT (K100389)Handpiece Headquarters2010-08-12
SYLE SMARTIP (K100833)Osspray, Ltd.2010-06-03
DENTAL HANDPIECE (K093971)North West Medical Instrument (Group) Co., Ltd.2010-04-22
CENTURY MODEL 105C (K093341)Sybron Dental Specialties, Inc.2010-04-05
SAF (SELF ADJUSTING FILE) (K092933)Redent-Nova , Ltd.2010-01-14
STARCARE HANDPIECE MAINTENANCE UNIT (K093072)Dentalez, Inc.2009-12-28
ROLENCE DENTAL HIGH SPEED HANDPIECE, RHP (K093084)Rolence Ent., Inc.2009-12-16
EMS AIR-FLOW HANDY PERIO (K092289)E.M.S Electro Medical Systems S.A2009-10-20
AIR TORX, MODEL TRA-200, TRA-200-CP3, TRA-200-CP4 (K091065)J. Morita USA, Inc.2009-10-16
CONTRA-ANGLE HANDPIECE KOMET OS30 (K090548)W&H Dentalwerk Buermoos GmbH2009-06-30
PRODRIVE LINE OF DENTAL HANDPIECES (K090369)Prodrive Systems, Inc.2009-02-27
PREMIUM SLOW SPEED; 20K AIR MOTOR, HEADS, CONTRA-ANGLES, STRAIGHT NOSECONES (K083101)Sable Industries, Inc.2009-02-23
EMS AIR-FLOW MASTER (K082791)E.M.S Electro Medical Systems S.A2009-02-18
CARE3 PLUS (K081811)Nakanishi, Inc.2009-01-21
A-DEC/W&H ALEGRA AIR-DRIVEN HIGHSPEED HANDPIECE, MODEL TE-97, TE-98, A-DEC/W&H ALEGRA HANDPIECE ATTACHMENT, MODEL HE-43 (K082716)A-Dec, Inc.2009-01-15
A-DEC/W&H PROFIN RECIPROCATING CONTRA-ANGLE HANDPIECE ATTACHMENT (K082827)A-Dec, Inc.2009-01-07
HHC, SCORE, HENRY SCHEIN CANISTER HANDPIECE (K080682)Handpiece Headquarters, Inc. - Hpr, Inc.2008-09-11
SUPERTORQUE HIGH-SPEED HANDPIECES AND GENTLEPOWER HANDPIECES AND ATTACHEMENTS (K073478)Sybron Dental Specialties, Inc.2008-09-03
ND LOW SPEED AIRMOTOR AND HANDPIECE, HIGHSPEED AIRTURBINE HANDPIECE, E-TYPE STRAIGHT NOSECONE AND CONTRA ANGLE (K073652)Nakamura Magnifier Co., Ltd.2008-03-20
CHALLENGER/CLASSIC PUSH BUTTON HANDPIECE (K080240)Promident, LLC2008-02-07
STATMATIC 31 HANDPIECE MAINTENANCE UNIT (K073319)Scican , Ltd.2008-02-04
AXIS SYSTEM (K072989)Dentsply Intl., Inc.2008-01-28
AXENIC DHP DISPOSABLE HIGH-PERFORMANCE HANDPIECE (K072754)Axenic Dental, Inc.2008-01-25
AIR-FLOW MASTER STANDARD (K073284)(Ems Sa) Electro Medical Systems2007-12-14
DO-ALL DENTAL HANDPIECE LUBRICANT (K073353)Prodrive Systems, Inc.2007-12-07
ACCESS AND ROTAMAX FIBER OPTIC HIGH SPEED DENTAL HANDPIECES (K072554)Sable Industries, Inc.2007-11-14
HI-SPEED TURBINE HANDPIECES, MODEL GSO1-B,GSO2-B,GSO3-B,GSO1-D,GSO2-D (K071561)Beijing North Pole Dental Handpiece Co., Ltd.2007-10-12
STATIS DENTAL HANDPIECES (K071891)Scican , Ltd.2007-09-13
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