Handpiece, Air-Powered, Dental

FDA product code EFB · Class I (low risk) · 21 CFR 872.4200 · Dental

261510(k) clearances
0PMA approvals
4recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K251389High speed air turbine handpieceEFB · Traditional Foshan Topmed Dental Co., Ltd.01/12/2026SE
K251388Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES…EFB · Traditional Foshan Topmed Dental Co., Ltd.01/12/2026SE
K242179Synea Fusion Handpieces (Intensiv & Profin)EFB · Traditional W&H Dentalwerk Bürmoos GmbH02/28/2025SE
K240337Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L)EFB · Traditional Guangdong Jinme Medical Technology Co., Ltd.11/13/2024SE
K241074High-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19, SCHF22), Dental Low…EFB · Traditional Foshan Soco Precision Instrument Co., Ltd.11/12/2024SE
K241880Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing System…EFB · Traditional Nakanishi, Inc.09/20/2024SE
K233122High Speed Air Turbine Handpiece (G100,G200,G300,G400,G450,G500,G600,G700,G700L,G800,G800…EFB · Traditional Litu Tech , Ltd.04/30/2024SE
K233308Air Motor (Model name: FX204 M4); Air Motor (Model name: M205)EFB · Traditional Nakanishi, Inc.04/25/2024SE
K220179High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air MotorsEFB · Traditional Foshan Coxo Medical Instrument Co., Ltd.09/22/2023SE
K232243EVO 700 series high speed handpieceEFB · Special Ttbio Corp.08/23/2023SE
K230888Titanium TurbineEFB · Traditional Nakanishi, Inc.06/02/2023SE
K221741TRAUS Air Dental HandpieceEFB · Traditional Saeshin Precision Co., Ltd.02/22/2023SE
K202674Medidenta High Speed HandpiecesEFB · Traditional Pac-Dent, Inc.12/12/2022SE
K212910Dental High-speed Turbine Handpiece, Dental Low-speed Turbine HandpieceEFB · Traditional Shenzhen Carejoy Technology Co., Ltd.11/17/2022SE
K221548Dental Air Polishing HandpieceEFB · Traditional Guilin Woodpecker Medical Instrument Co., Ltd.09/28/2022SE
K221814OK HandpieceEFB · Traditional Jaintek Co.,Ltd07/15/2022SE
K203791Stainless TurbineEFB · Traditional Nakanishi, Inc.06/21/2022SE
K202371Highspeed Airturbine HandpieceEFB · Traditional Beijing Dongbo Dental Handpiece Co., Ltd.11/08/2021SE
K202786Dental Low-speed Handpieces and AccessoriesEFB · Traditional Microp Technology (Taiwan), Inc.09/03/2021SE
K193264Disposable High Speed Air Turbine HandpieceEFB · Traditional Ningbo Hpdove Dental Instruments Co., Ltd.08/11/2020SE
K181691High-speed air turbine handpiece / Low-speed air turbine handpieceEFB · Traditional Foshan Wenjian Medical Instrument Co., Ltd.05/26/2020SE
K190509Lubrina 2EFB · Traditional J. Morita USA, Inc.03/04/2020SE
K192409Midwest Rhino XE and Air Motor MEFB · Traditional Dentsply Sirona01/13/2020SE
K192412SD500 Elite LubeFree High Speed Handpiece, SD500 Elite Lubricated High Speed Handpiece…EFB · Traditional Dentalez, Inc.01/06/2020SE
K190508EVO 450 series High Speed HandpiecesEFB · Traditional Ttbio Corp.12/11/2019SE
K181900Dental high speed handpiece, Dental low speed handpieceEFB · Traditional Foshan Cicada Dental Instrument Co, Ltd.12/09/2019SE
K181110PROPHYflex 4EFB · Traditional Kaltenbach & Voigt GmbH04/10/2019SE
K173943Dental High-speed Handpiece and AccessoriesEFB · Traditional Microp Technology (Taiwan), Inc.07/24/2018SE
K172543High-speed Turbine Handpieces for Single UseEFB · Traditional Beijing Dongbo Dental Handpiece Co., Ltd.07/11/2018SE
K173465Concentrix MX-AC High-Speed HandpieceEFB · Traditional Dentalez, Inc.03/28/2018SE
K171174PERIO-FLOW nozzleEFB · Traditional E.M.S Electro Medical Systems S.A12/18/2017SE
K171553W&H Assistina TwinEFB · Traditional W&H Dentalwerk Buermoos GmbH12/08/2017SE
K170236Dental Low-speed Turbine HandpieceEFB · Traditional Guangdong Jinme Medical Technology Co., Ltd.11/21/2017SE
K170229Dental High-speed Turbine HandpieceEFB · Traditional Guangdong Jinme Medical Technology Co., Ltd.11/08/2017SE
K170261Premium Plus Prophy Air MotorEFB · Abbreviated Premium Plus International Limited10/19/2017SE
K163483PANA SPRAY PlusEFB · Traditional Nakanishi, Inc.08/15/2017SE
K162926Air-Powered Handpieces and Handpiece AttachmentsEFB · Traditional W&H Dentalwerk Burmoos GmbH02/23/2017SE
K160410WOlf High Speed Handpieces - Medium head, WOlf High Speed Handpieces - Small headEFB · Traditional Dental Savings Club09/29/2016SE
K153411430 Torque High-Speed Handpiece Series - 430 SWL Torque High Speed Handpiece, 430 SW…EFB · Traditional Dentalez, Inc.04/08/2016SE
K151912AIR-FLOW handy 3.0 PLUSEFB · Traditional E.M.S Electro Medical Systems S.A02/03/2016SE
K152146High Speed Handpieces and AccessoriesEFB · Traditional Codent Technical Industry Co., Ltd.12/08/2015SE
K143704Advanced Air SystemEFB · Traditional W&H Dentalwerk Buermoos GmbH11/23/2015SE
K141886MDK HandpiecesEFB · Traditional Modern Korea Co., Ltd.05/13/2015SE
K141576Maxima PRO 45LEFB · Traditional Kavo DO Brasil Industria E Comercio Ltda05/04/2015SE
K150798Codent Low Speed Dental Handpieces and AccessoriesEFB · Special Codent Technical Industry Co., Ltd.04/24/2015SE
K141183Evo 500 Series High Speed Handpieces/Tiger 500/300/101 Series High Speed HandpiecesEFB · Abbreviated Ttbio Corp.02/27/2015SE
K143183Maxima XTEND Handpiece Maintenance SystemEFB · Traditional Handpiece Headquarters02/17/2015SE
K142063#8C Renegade Dental HandpieceEFB · Traditional Handpiece Club, LLC10/28/2014SE
K141221Lares Ultralite Prostyle High-Speed Dental Handpieces, Lares Euro Prostyle High-Speed…EFB · Abbreviated Lares Research, Inc.10/28/2014SE
K133069Codent Low Speed Dental Handpieces and AccessoriesEFB · Traditional Codent Technical Industry Co., Ltd.10/24/2014SE
K131319T1/T2/T3 Turbine FamilyEFB · Traditional Sirona Dental Systems GmbH05/30/2014SE
K132478Air-Flow Handy 3.0EFB · Traditional E.M.S Electro Medical Systems S.A04/11/2014SE
K133170Quick Jet MEFB · Traditional Micron Corp.03/28/2014SE
K132480Air-Flow Handy 3.0 PerioEFB · Traditional E.M.S Electro Medical Systems S.A02/24/2014SE
K130560Mastertorque Lux 8900 LEFB · Traditional Kaltenbach & Voigt GmbH09/27/2013SE
K130455430 SWL 45 and 430 SW 45 High-Speed HandpiecesEFB · Traditional Dentalez Group, Stardental Division09/25/2013SE
K131014Pana Spray PlusEFB · Traditional Nsk America Corp.08/12/2013SE
K120218Tek USA E-Generator Integrated LED Handpiece (High & Low Speed Air Turbnine Dental…EFB · Traditional Palm Beach Dental Supply D/B/A Tek USA06/29/2012SE
K112024Ti-Max X450EFB · Traditional Nakanishi, Inc.06/20/2012SE
K113674Spray & Clean Handpiece Cleaner& Lubricant Maxima Handpiece Cleaner & Lubricant Ezcare…EFB · Traditional Handpiece Headquarters, Inc. - Hpr, Inc.04/05/2012SE
K113655Ti-Max X TurbineEFB · Traditional Nakanishi, Inc.03/05/2012SE
K113222ND Lowspeed Airmotor,Nd Highspeed Airturbine HandpieceEFB · Traditional Nakamura Dental Handpiece Mfg. Co., Ltd.02/23/2012SE
K111249OrthoslenderizerEFB · Traditional Orthomatics, Inc.02/08/2012SE
K112673Prophy-Mate NeoEFB · Traditional Nakanishi, Inc.02/07/2012SE
K113301Concenpiece,High-Speed Handpiece SeriesEFB · Traditional Dentalez, Inc.01/23/2012SE
K112869Easyprophy Series Air Polish Devices, Models Easyprophy 200 and Easyprophy 400EFB · Traditional Beyes Dental Canada, Inc.12/16/2011SE
K112623Airlight Dental HandpieceEFB · Traditional Beyes Dental Canada, Inc.12/16/2011SE
K110379Air-N-GoEFB · Traditional Satelec12/08/2011SE
K102517Tiger 500 Series High Speed Handpieces and AttachmentsEFB · Traditional Thunder Tiger Corp.04/27/2011SE
K100731Bosworth Air PolisherEFB · Traditional Harry J. Bosworth Co.12/03/2010SE
K101551Pacemaker High-Speed Handpiece Model Pm-Mq, Pm-MEFB · Traditional Delma Medical Instrument (Guangzhou) Co., Ltd.09/09/2010SE
K101717Dental Handpieces, Models: Karam Std/Mini; Breeze Std/Mini: Karam 45; Dexor 45; Karam 4H…EFB · Traditional Aerobine, Inc.08/20/2010SE
K100389HHC Push-Button Replacement Turbine for Midwest Tradition Handpiece Model MW Turbine…EFB · Traditional Handpiece Headquarters08/12/2010SE
K100833Syle SmartipEFB · Traditional Osspray, Ltd.06/03/2010SE
K093971Dental HandpieceEFB · Traditional North West Medical Instrument (Group) Co., Ltd.04/22/2010SE
K093341Century Model 105CEFB · Traditional Sybron Dental Specialties, Inc.04/05/2010SE
K092933Saf (Self Adjusting File)EFB · Traditional Redent-Nova , Ltd.01/14/2010SE
K093072Starcare Handpiece Maintenance UnitEFB · Traditional Dentalez, Inc.12/28/2009SE
K093084Rolence Dental High Speed Handpiece, RHPEFB · Traditional Rolence Ent., Inc.12/16/2009SE
K092289EMS Air-Flow Handy PerioEFB · Traditional E.M.S Electro Medical Systems S.A10/20/2009SE
K091065Air Torx, Model TRA-200, TRA-200-CP3, TRA-200-CP4EFB · Traditional J. Morita USA, Inc.10/16/2009SE
K090548Contra-Angle Handpiece Komet OS30EFB · Abbreviated W&H Dentalwerk Buermoos GmbH06/30/2009SE
K090369Prodrive Line of Dental HandpiecesEFB · Traditional Prodrive Systems, Inc.02/27/2009SE
K083101Premium Slow Speed; 20K Air Motor, Heads, Contra-Angles, Straight NoseconesEFB · Abbreviated Sable Industries, Inc.02/23/2009SE
K082791EMS Air-Flow MasterEFB · Traditional E.M.S Electro Medical Systems S.A02/18/2009SE
K081811CARE3 PlusEFB · Traditional Nakanishi, Inc.01/21/2009SE
K082716A-Dec/W&H Alegra Air-Driven Highspeed Handpiece, Model TE-97, TE-98, A-Dec/W&H Alegra…EFB · Abbreviated A-Dec, Inc.01/15/2009SE
K082827A-Dec/W&H Profin Reciprocating Contra-Angle Handpiece AttachmentEFB · Abbreviated A-Dec, Inc.01/07/2009SE
K080682HHC, Score, Henry Schein Canister HandpieceEFB · Abbreviated Handpiece Headquarters, Inc. - Hpr, Inc.09/11/2008SE
K073478Supertorque High-Speed Handpieces and Gentlepower Handpieces and AttachementsEFB · Traditional Sybron Dental Specialties, Inc.09/03/2008SE
K073652ND Low Speed Airmotor and Handpiece, Highspeed Airturbine Handpiece, E-Type Straight…EFB · Traditional Nakamura Magnifier Co., Ltd.03/20/2008SE
K080240Challenger/Classic Push Button HandpieceEFB · Traditional Promident, LLC02/07/2008SE
K073319Statmatic 31 Handpiece Maintenance UnitEFB · Traditional Scican , Ltd.02/04/2008SE
K072989Axis SystemEFB · Traditional Dentsply Intl., Inc.01/28/2008SE
K072754Axenic DHP Disposable High-Performance HandpieceEFB · Traditional Axenic Dental, Inc.01/25/2008SE
K073284Air-Flow Master StandardEFB · Special (Ems Sa) Electro Medical Systems12/14/2007SE
K073353Do-All Dental Handpiece LubricantEFB · Traditional Prodrive Systems, Inc.12/07/2007SE
K072554Access and Rotamax Fiber Optic High Speed Dental HandpiecesEFB · Abbreviated Sable Industries, Inc.11/14/2007SE
K071561Hi-Speed Turbine Handpieces, Model GSO1-B,GSO2-B,GSO3-B,GSO1-D,GSO2-DEFB · Traditional Beijing North Pole Dental Handpiece Co., Ltd.10/12/2007SE
K071891Statis Dental HandpiecesEFB · Abbreviated Scican , Ltd.09/13/2007SE
K071965I-SurgeEFB · Traditional Satelec09/10/2007SE
K070663A-Dec/W&H Synea Air-Driven Highspeed Handpiece, Model TA-98, TA-97, A-Dec/W&H Synea…EFB · Abbreviated A-Dec, Inc.07/05/2007SE
K070869Prophy Star 3 Hygiene Handpiece, Model 264422EFB · Traditional Dentalez, Inc.06/15/2007SE
K070074Lubrina, Model HIM-1EFB · Traditional J. Morita USA, Inc.05/31/2007SE
K070297Clearview Dental Handpiece Lubricator and LubricantEFB · Traditional Dental Air Solutions of Nc, Inc.02/05/2007SE
K070001Master Classic 5K Low Speed Handpiece, 20K Low Speed Handpiece, TM5 Low Speed Handpiece…EFB · Special Mti Precision Products02/02/2007SE
K070155Integrity Low Speed Dental Air Handpiece and Attachment, Models: Motor Int-E, Motor…EFB · Traditional Osseo Scientific, LLC01/25/2007SE
K062947High Speed Air Turbine Handpiece, Models Super-Air and Super-Qd SeriesEFB · Traditional Peng Lim Enterprise Co., Ltd.12/14/2006SE
K062812Dental Air-Powered Handpiece, Models Tiger 300T, 300K, 300W, 300B and 300NEFB · Traditional Thunder Tiger Corp.11/28/2006SE
K062740Jindell High Spped Air Turbine Handpiece, Models SW, SP, Su, Etu, MuEFB · Traditional Jindell Medical Instruments Co., Ltd.11/02/2006SE
K063110CST61 High Speed Turbine HandpieceEFB · Traditional Shanghai Dental Instrument Factory10/26/2006SE
K062418K-Spray, Model 085-2715EFB · Traditional Scican10/19/2006SE
K062219Prodrive Systems Replacement TurbineEFB · Traditional Prodrive Systems, Inc.08/04/2006SE
K053368Interproximal Reduction SystemEFB · Traditional Dentsply International03/29/2006SE
K052822Dental Air-Powered Handpiece, Models Tiger 100, 101, 200, 201 and 202EFB · Traditional Thunder Tiger Corp.01/20/2006SE
K052700Pana-SprayEFB · Traditional Nsk America Corp.12/20/2005SE
K051872Mk-Dent Low Speed Handpieces and Accessories Including Spare Parts, Tubings, and Light…EFB · Traditional Mk-Dent GmbH10/03/2005SE
K043497Air Solfy, Models AS-4H, AS-4H-O, AS-4H-V, AS-4H-OV, AS-1,AS-1-0,AS-1-V, AS-1-OVEFB · Traditional J. Morita USA, Inc.03/21/2005SE
K043498Twin Power Turbine High Speed Air Turbine Dental HandpieceEFB · Traditional J. Morita USA, Inc.02/16/2005SE
K042787Is 40 MicromotorEFB · Traditional Satelec12/17/2004SE
K041755Cromax High Speed Turbine HandpieceEFB · Traditional J.R. Medical Technologies, Inc.10/22/2004SE
K041141Dentsply Cavitron Jet Wave Air Polishing Prophylaxis System, Model G125EFB · Traditional Dentsply Intl.06/16/2004SE
K033812Siroair L Air ScalerEFB · Traditional Sirona Dental Systems GmbH02/23/2004SE
K033213Codent Dental Air-Powered Handpiece, Model HPSEFB · Traditional Codent Technical Industry Co., Ltd.02/06/2004SE
K032395Prophy-MateEFB · Traditional Nakanishi, Inc.10/17/2003SE
K032234Mk-Dent High Speed Dental Handpiece, Models HS 4021K, 4011K, 4012K, and HS 6021K, 6011K…EFB · Traditional Mk-Dent GmbH10/02/2003SE
K031851Dentiseptic HPCEFB · Traditional Bethel, Inc.08/01/2003SE
K031145Estylus Electric Motor SystemEFB · Traditional Dentsply Intl.07/15/2003SE
K031868ProphypearlsEFB · Special Kavo America07/09/2003SE
K022535Microtech Push Button Handpiece, Model MHS-A100EFB · Traditional Microtech10/22/2002SE
K022119EMS Air-Flow Handy 2 Dental HandpieceEFB · Special Electro Medical Systems SA07/25/2002SE
K012308Kavo QuattrocareEFB · Traditional Kavo America06/26/2002SE
K012720Tulsa Contra AnglesEFB · Traditional Dentsply Intl.11/08/2001SE
K010127W & H AssistinaEFB · Traditional A-Dec, Inc.10/05/2001SE
K003518Rapidd Highspeed Dental HandpieceEFB · Traditional Dentsply Intl.01/09/2001SE
K000834Castellni Air Powered Handpieces Syringes: Three Steril, Multisteril Turbins: Cleanair…EFB · Traditional Castellini S.P.A.12/14/2000SE
K000848TDK HandpiecesEFB · Traditional Orasystems10/05/2000SE
K000847OralubeEFB · Traditional Orasystems09/27/2000SE
K000710MD 10, Sem, SM 12, CBMEFB · Traditional Nouvag AG05/11/2000SE
K000547Atr TecnikaEFB · Traditional Advanced Technology Research (A.T.R.) S.R.P.05/03/2000SE
K000049Suni MaxEFB · Traditional Satelec04/04/2000SE
K993526Synea - LS Low-Speed HandpieceEFB · Traditional A-Dec, Inc.01/11/2000SE
K971732Dental HandpieceEFB · Traditional Pauline M. Nicholls01/11/2000SE
K991401Atr 3000, Atr 2000, Implant-ProEFB · Traditional Advanced Technology Research (A.T.R.) S.R.P.12/15/1999SE
K991492LC CompositeEFB · Traditional Harry J. Bosworth Co.12/02/1999SE
K992380Endo-Eze Motor and HandpieceEFB · Traditional Ultradent Products, Inc.10/13/1999SE
K991857Airflow HandyEFB · Traditional Electro Medical Systems, Inc.10/07/1999SE
K992011Synea-Hs High Speed-HandpieceEFB · Traditional A-Dec, Inc.09/10/1999SE
K991701Mach-Sigma Handpiece, Ultrapush, Models Mach-Sigma Mu (Mini Head), Mach-Sigma Su (Std.…EFB · Traditional Nsk Nakanishi, Inc.08/10/1999SE
K984244ORL-E-92 Surgical Drill SystemEFB · Traditional Bien Air USA, Inc.02/23/1999SE
K981679TCM 3000 and TCM EndoEFB · Traditional Nouvag AG02/09/1999SE
K983183Gyro Long-Life,Black Pearl Eco, Ondine &Croma, Prestige, Bora, Aquilon, MC2,MC3, Basch…EFB · Traditional Bien Air USA, Inc.12/10/1998SE
K983168Avant High Speed Handpiece, Avant Fiber Optic High Speed Handpiece, Model #'S Avant HS…EFB · Traditional Ora Innovations, Inc.11/18/1998SE
K982593Lube Free Autochuck Turbine with Vortex Air Seal for Use with Star Dental 430 Series…EFB · Traditional Dentalez Group10/22/1998SE
K980585MillenniumEFB · Traditional Biolase Technology, Inc.10/08/1998SE
K982050Model MS-2 HandpieceEFB · Traditional Parkell, Inc.09/02/1998SE
K981869Pro-Flex Disposable Prophy AngleEFB · Traditional Professional Dental Mfg., Inc.08/11/1998SE
K981990MRS-400, Maxi 400, MRSL-400, Maxi 400LEFB · Traditional D.B.I. America Corp.06/22/1998SE
K980162Mach-Sigma Handpiece, UltrapushEFB · Traditional Nsk Nakanishi, Inc.06/05/1998SE
K974670Athena 1:1 Contra Angle, Athena 4:1 Contra Angle, Athena 16:1 Contra Angle, Athena 64:1…EFB · Traditional Athena Technology, Inc.03/13/1998SE
K974671Athena 20R S Type Slow Speed Handpiece MotorEFB · Traditional Athena Technology, Inc.03/11/1998SE
K973876Prophyflex 2, Model 2012EFB · Traditional Kavo America12/19/1997SE
K972436T1 Line Dental HandpiecesEFB · Traditional Siemens AG09/22/1997SE
K972376Impact Air 45 Handpiece for Periodontal UseEFB · Traditional Glenwood, LLC09/10/1997SE
K972375Impact Air 45 Handpiece for Endodontic UseEFB · Traditional Glenwood, LLC09/10/1997SE
K971774NSK Push-Button Midwest Replacement Turbine:For Quietair and TraditionEFB · Traditional Nsk Nakanishi, Inc.06/20/1997SE
K970104Sani-ShieldEFB · Traditional Dw Industries, Inc.05/06/1997SE
K963843Electric Surgical Irrigation System - Dual Controller UnitEFB · Traditional Micro Motors, Inc.03/31/1997SE
K961275Sirius 10, 10L, 40, 40LEFB · Traditional Micro-Mega Societe Anonyme01/17/1997SE
K961235Sirius 180, 180L, 230, 230LEFB · Traditional Micro-Mega Societe Anonyme01/08/1997SE
K963664Dental Handpiece and AccessoryEFB · Traditional Filmtech, Inc.10/24/1996SE
K962877Midwest 300 SeEFB · Traditional Midwest Dental Products Corp.10/18/1996SE
K963050Tradition P, Push Button HandpieceEFB · Traditional Midwest Dental Products Corp.10/11/1996SE
K962542Air Motor Handpiece TN-102EFB · Traditional Nsk Nakanishi, Inc.09/24/1996SE
K962543Alpha Air Handpiece, Ultra-Push, Al-Su, Al-Mu, Al-TuEFB · Traditional Nsk Nakanishi, Inc.09/11/1996SE
K952927Impact Air 45 4-HOLEEFB · Traditional Palisades Pharmaceutics, Inc.08/06/1996SE
K961076MM 324EFB · Traditional Micro-Mega Societe Anonyme04/26/1996SE
K961163Lares Research AS-1 Lowspeed HandpieceEFB · Traditional Lares Research, Inc.04/23/1996SE
K960541Lynx Dpa Disposable Prophy AngleEFB · Traditional Mti Precision Products03/28/1996SE
K955655Midwest OneEFB · Traditional Midwest Dental Products Corp.03/05/1996SE
K960352Allrap/Slip-N-GripEFB · Traditional Dental Disposables Intl., Inc.02/21/1996SE
K955654Shortstop Disposable Prophy AngleEFB · Traditional Spintech, Inc.02/08/1996SE
K945256MTC 7707 High Speed Air TurbineEFB · Traditional Mtc Industries and Research, Ltd.01/29/1996SE
K954722Micro-Dispenser 7000 & Microdispenser 8000EFB · Traditional Nouvag AG01/16/1996SE
K954991Phase Change Dental LubricantEFB · Traditional Phase Change01/04/1996SE
K954012Disposable Prophy HandpieceEFB · Traditional Denticator Intl., Inc.11/08/1995SE
K945734W&H Roto Quick CouplingsEFB · Traditional A-Dec, Inc.10/05/1995SE
K944719W&H 100 Series Low SpeedEFB · Traditional A-Dec, Inc.10/05/1995SE
K944718W&H 900 Incolight LT HandpieceEFB · Traditional A-Dec, Inc.10/05/1995SE
K944713W&H Micro Air Motor LT25EFB · Traditional A-Dec, Inc.08/28/1995SE
K944714W&H Corsair ScalerEFB · Traditional A-Dec, Inc.08/25/1995SE
K944712W&H Micro Motor E25 (Without Light)EFB · Traditional A-Dec, Inc.08/25/1995SE
K944711W&H Air Motor A25EFB · Traditional A-Dec, Inc.08/25/1995SE
K932333Protectoral Ultrasonic Handpiece ProcessorEFB · Traditional Gull Laboratories, Inc.08/15/1995SE
K944709W&H 896 Top Ligh HighspeedEFB · Traditional A-Dec, Inc.06/08/1995SE
K944717W&H 798 Top Air Turbine Triple SprayEFB · Traditional A-Dec, Inc.06/02/1995SE
K944716W&H 796 Top Air Turbine Mini-HeadEFB · Traditional A-Dec, Inc.06/02/1995SE
K944715W&H 795 Top Air Turbine Single SprayEFB · Traditional A-Dec, Inc.06/02/1995SE
K944710W&H 898 Top Light HighspeedEFB · Traditional A-Dec, Inc.06/02/1995SE
K944708W&H 895 Top Ligh Highspeed Fiberoptic Single SprayEFB · Traditional A-Dec, Inc.06/02/1995SE

Recalls

RecallProductFirmInitiated
Z-1208-2023 Class IISciCan STATIS SL S10001 Dental Handpieces-Intended for the removal of carious material…Screw connection between the turbine head and the push button may loosen and fall off during the treatment… Coltene Whaledent Inc01/20/2023Open, Classified
Z-2674-2016 Class IIDiamond Coated Tips and Burs are accessories to the air powered dental handpiece (S-MAX…Through an error, the labeling failed to include the symbol or other text indicating that the diamond coated… Nakanishi Inc.07/08/2016Terminated
Z-2044-2014 Class IILynx TM20 Torquemaster Low Speed Handpiece MTI Dental ProductsSharp edge on the body/housing of the Lynx TM20 TorqueMaster Low Speed Handpiece. MTI Precision Products LLC.05/07/2012Terminated
Z-0289-2007 KaVo QUATTROcare Spray, 500 ml aerosol can; a maintenance spray for lubrication of KaVo…The QUATTROcare Spray cans may allow the gas (propane) to escape from the can under certain circumstances.… Kavo America Corporation11/22/2006Terminated