Product Code: EFB FDA class 1 21 CFR 872.4200

Handpiece, Air-Powered, Dental

Dental

The Air-Powered Dental Handpiece is a dental device driven by compressed air that rotates dental burs at high or low speeds for cutting tooth structure, removing decay, and finishing restorations. It is classified as FDA Class 1, the lowest risk category, subject only to general controls and no premarket submission is required. The product code is EFB and the applicable regulation is 21 CFR 872.4200, under the Dental medical specialty. This device is eligible for third-party 510(k) review.

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510(k)s

261

FEI Numbers

Registration Numbers

Unique Applicants

144

Years Active

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Basic Information

Product Code: EFB
Device Class: FDA class 1
Regulation Number: 872.4200
Medical Specialty: Dental
Review Panel: DE
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 261 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K251389	High speed air turbine handpiece	Jan 12, 2026	Substantially Equivalent	Foshan Topmed Dental Co., Ltd.
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)	Jan 12, 2026	Substantially Equivalent	Foshan Topmed Dental Co., Ltd.
K242179	Synea Fusion Handpieces (Intensiv & Profin)	Feb 28, 2025	Substantially Equivalent	W&H Dentalwerk Bürmoos GmbH
K240337	Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L)	Nov 13, 2024	Substantially Equivalent	Guangdong Jinme Medical Technology Co., Ltd.
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)	Nov 12, 2024	Substantially Equivalent	Foshan Soco Precision Instrument Co., Ltd.
K241880	Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing System (Perio Mate Nozzle Tip)	Sep 20, 2024	Substantially Equivalent	Nakanishi, Inc.
K233122	High Speed Air Turbine Handpiece (G100,G200,G300,G400,G450,G500,G600,G700,G700L,G800,G800L)	Apr 30, 2024	Substantially Equivalent	Litu Tech , Ltd.
K233308	Air Motor (Model name: FX204 M4); Air Motor (Model name: M205)	Apr 25, 2024	Substantially Equivalent	Nakanishi, Inc.
K220179	High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air Motors	Sep 22, 2023	Substantially Equivalent	Foshan Coxo Medical Instrument Co., Ltd.
K232243	EVO 700 series high speed handpiece	Aug 23, 2023	Substantially Equivalent	Ttbio Corp.
K230888	Titanium Turbine	Jun 02, 2023	Substantially Equivalent	Nakanishi, Inc.
K221741	TRAUS Air Dental Handpiece	Feb 22, 2023	Substantially Equivalent	Saeshin Precision Co., Ltd.
K202674	Medidenta High Speed Handpieces	Dec 12, 2022	Substantially Equivalent	Pac-Dent, Inc.
K212910	Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece	Nov 17, 2022	Substantially Equivalent	Shenzhen Carejoy Technology Co., Ltd.
K221548	Dental Air Polishing Handpiece	Sep 28, 2022	Substantially Equivalent	Guilin Woodpecker Medical Instrument Co., Ltd.
K221814	OK Handpiece	Jul 15, 2022	Substantially Equivalent	Jaintek Co.,Ltd
K203791	Stainless Turbine	Jun 21, 2022	Substantially Equivalent	Nakanishi, Inc.
K202371	Highspeed Airturbine Handpiece	Nov 08, 2021	Substantially Equivalent	Beijing Dongbo Dental Handpiece Co., Ltd.
K202786	Dental Low-speed Handpieces and Accessories	Sep 03, 2021	Substantially Equivalent	Microp Technology (Taiwan), Inc.
K193264	Disposable High Speed Air Turbine Handpiece	Aug 11, 2020	Substantially Equivalent	Ningbo Hpdove Dental Instruments Co., Ltd.
K181691	High-speed air turbine handpiece / Low-speed air turbine handpiece	May 26, 2020	Substantially Equivalent	Foshan Wenjian Medical Instrument Co., Ltd.
K190509	Lubrina 2	Mar 04, 2020	Substantially Equivalent	J. Morita USA, Inc.
K192409	Midwest Rhino XE and Air Motor M	Jan 13, 2020	Substantially Equivalent	Dentsply Sirona
K192412	SD500 Elite LubeFree High Speed Handpiece, SD500 Elite Lubricated High Speed Handpiece, SD500 Pro LubeFree High Speed Handpiece, Pro Lubricated High Speed Handpiece	Jan 06, 2020	Substantially Equivalent	Dentalez, Inc.
K190508	EVO 450 series High Speed Handpieces	Dec 11, 2019	Substantially Equivalent	Ttbio Corp.
K181900	Dental high speed handpiece, Dental low speed handpiece	Dec 09, 2019	Substantially Equivalent	Foshan Cicada Dental Instrument Co, Ltd.
K181110	PROPHYflex 4	Apr 10, 2019	Substantially Equivalent	Kaltenbach & Voigt GmbH
K173943	Dental High-speed Handpiece and Accessories	Jul 24, 2018	Substantially Equivalent	Microp Technology (Taiwan), Inc.
K172543	High-speed Turbine Handpieces for Single Use	Jul 11, 2018	Substantially Equivalent	Beijing Dongbo Dental Handpiece Co., Ltd.
K173465	Concentrix MX-AC High-Speed Handpiece	Mar 28, 2018	Substantially Equivalent	Dentalez, Inc.
K171174	PERIO-FLOW nozzle	Dec 18, 2017	Substantially Equivalent	E.M.S Electro Medical Systems S.A
K171553	W&H Assistina Twin	Dec 08, 2017	Substantially Equivalent	W&H Dentalwerk Buermoos GmbH
K170236	Dental Low-speed Turbine Handpiece	Nov 21, 2017	Substantially Equivalent	Guangdong Jinme Medical Technology Co., Ltd.
K170229	Dental High-speed Turbine Handpiece	Nov 08, 2017	Substantially Equivalent	Guangdong Jinme Medical Technology Co., Ltd.
K170261	Premium Plus Prophy Air Motor	Oct 19, 2017	Substantially Equivalent	Premium Plus International Limited
K163483	PANA SPRAY Plus	Aug 15, 2017	Substantially Equivalent	Nakanishi, Inc.
K162926	Air-Powered Handpieces and Handpiece Attachments	Feb 23, 2017	Substantially Equivalent	W&H Dentalwerk Burmoos GmbH
K160410	WOlf High Speed Handpieces - Medium head, WOlf High Speed Handpieces - Small head	Sep 29, 2016	Substantially Equivalent	Dental Savings Club
K153411	430 Torque High-Speed Handpiece Series - 430 SWL Torque High Speed Handpiece, 430 SW Torque High Speed Handpiece	Apr 08, 2016	Substantially Equivalent	Dentalez, Inc.
K151912	AIR-FLOW handy 3.0 PLUS	Feb 03, 2016	Substantially Equivalent	E.M.S Electro Medical Systems S.A
K152146	High Speed Handpieces and Accessories	Dec 08, 2015	Substantially Equivalent	Codent Technical Industry Co., Ltd.
K143704	Advanced Air System	Nov 23, 2015	Substantially Equivalent	W&H Dentalwerk Buermoos GmbH
K141886	MDK HANDPIECES	May 13, 2015	Substantially Equivalent	Modern Korea Co., Ltd.
K141576	Maxima PRO 45L	May 04, 2015	Substantially Equivalent	Kavo DO Brasil Industria E Comercio Ltda
K150798	Codent Low Speed Dental Handpieces and Accessories	Apr 24, 2015	Substantially Equivalent	Codent Technical Industry Co., Ltd.
K141183	EVO 500 SERIES HIGH SPEED HANDPIECES/TIGER 500/300/101 SERIES HIGH SPEED HANDPIECES	Feb 27, 2015	Substantially Equivalent	Ttbio Corp.
K143183	Maxima XTEND Handpiece Maintenance System	Feb 17, 2015	Substantially Equivalent	Handpiece Headquarters
K142063	#8C RENEGADE DENTAL HANDPIECE	Oct 28, 2014	Substantially Equivalent	Handpiece Club, LLC
K141221	LARES ULTRALITE PROSTYLE HIGH-SPEED DENTAL HANDPIECES, LARES EURO PROSTYLE HIGH-SPEED DENTAL HANDPIECES, LARES TURBO+ PR	Oct 28, 2014	Substantially Equivalent	Lares Research, Inc.
K133069	CODENT LOW SPEED DENTAL HANDPIECES AND ACCESSORIES	Oct 24, 2014	Substantially Equivalent	Codent Technical Industry Co., Ltd.
K131319	T1/T2/T3 TURBINE FAMILY	May 30, 2014	Substantially Equivalent	Sirona Dental Systems GmbH
K132478	AIR-FLOW HANDY 3.0	Apr 11, 2014	Substantially Equivalent	E.M.S Electro Medical Systems S.A
K133170	QUICK JET M	Mar 28, 2014	Substantially Equivalent	Micron Corp.
K132480	AIR-FLOW HANDY 3.0 PERIO	Feb 24, 2014	Substantially Equivalent	E.M.S Electro Medical Systems S.A
K130560	MASTERTORQUE LUX 8900 L	Sep 27, 2013	Substantially Equivalent	Kaltenbach & Voigt GmbH
K130455	430 SWL 45 AND 430 SW 45 HIGH-SPEED HANDPIECES	Sep 25, 2013	Substantially Equivalent	Dentalez Group, Stardental Division
K131014	PANA SPRAY PLUS	Aug 12, 2013	Substantially Equivalent	Nsk America Corp.
K120218	TEK USA E-GENERATOR INTEGRATED LED HANDPIECE (HIGH & LOW SPEED AIR TURBNINE DENTAL HANDPIECE)	Jun 29, 2012	Substantially Equivalent	Palm Beach Dental Supply D/B/A Tek USA
K112024	TI-MAX X450	Jun 20, 2012	Substantially Equivalent	Nakanishi, Inc.
K113674	SPRAY & CLEAN HANDPIECE CLEANER& LUBRICANT MAXIMA HANDPIECE CLEANER & LUBRICANT EZCARE HANDPIECE CLEANER & LUBRICANT	Apr 05, 2012	Substantially Equivalent	Handpiece Headquarters, Inc. - Hpr, Inc.
K113655	TI-MAX X TURBINE	Mar 05, 2012	Substantially Equivalent	Nakanishi, Inc.
K113222	ND LOWSPEED AIRMOTOR,ND HIGHSPEED AIRTURBINE HANDPIECE	Feb 23, 2012	Substantially Equivalent	Nakamura Dental Handpiece Mfg. Co., Ltd.
K111249	ORTHOSLENDERIZER	Feb 08, 2012	Substantially Equivalent	Orthomatics, Inc.
K112673	PROPHY-MATE NEO	Feb 07, 2012	Substantially Equivalent	Nakanishi, Inc.
K113301	CONCENPIECE,HIGH-SPEED HANDPIECE SERIES	Jan 23, 2012	Substantially Equivalent	Dentalez, Inc.
K112869	EASYPROPHY SERIES AIR POLISH DEVICES, MODELS EASYPROPHY 200 AND EASYPROPHY 400	Dec 16, 2011	Substantially Equivalent	Beyes Dental Canada, Inc.
K112623	AIRLIGHT DENTAL HANDPIECE	Dec 16, 2011	Substantially Equivalent	Beyes Dental Canada, Inc.
K110379	AIR-N-GO	Dec 08, 2011	Substantially Equivalent	Satelec
K102517	TIGER 500 SERIES HIGH SPEED HANDPIECES AND ATTACHMENTS	Apr 27, 2011	Substantially Equivalent	Thunder Tiger Corp.
K100731	BOSWORTH AIR POLISHER	Dec 03, 2010	Substantially Equivalent	Harry J. Bosworth Co.
K101551	PACEMAKER HIGH-SPEED HANDPIECE MODEL PM-MQ, PM-M	Sep 09, 2010	Substantially Equivalent	Delma Medical Instrument (Guangzhou) Co., Ltd.
K101717	DENTAL HANDPIECES, MODELS: KARAM STD/MINI; BREEZE STD/MINI: KARAM 45; DEXOR 45; KARAM 4H COUPLING	Aug 20, 2010	Substantially Equivalent	Aerobine, Inc.
K100389	HHC PUSH-BUTTON REPLACEMENT TURBINE FOR MIDWEST TRADITION HANDPIECE MODEL MW TURBINE REPLACEMENT	Aug 12, 2010	Substantially Equivalent	Handpiece Headquarters
K100833	SYLE SMARTIP	Jun 03, 2010	Substantially Equivalent	Osspray, Ltd.
K093971	DENTAL HANDPIECE	Apr 22, 2010	Substantially Equivalent	North West Medical Instrument (Group) Co., Ltd.
K093341	CENTURY MODEL 105C	Apr 05, 2010	Substantially Equivalent	Sybron Dental Specialties, Inc.
K092933	SAF (SELF ADJUSTING FILE)	Jan 14, 2010	Substantially Equivalent	Redent-Nova , Ltd.
K093072	STARCARE HANDPIECE MAINTENANCE UNIT	Dec 28, 2009	Substantially Equivalent	Dentalez, Inc.
K093084	ROLENCE DENTAL HIGH SPEED HANDPIECE, RHP	Dec 16, 2009	Substantially Equivalent	Rolence Ent., Inc.
K092289	EMS AIR-FLOW HANDY PERIO	Oct 20, 2009	Substantially Equivalent	E.M.S Electro Medical Systems S.A
K091065	AIR TORX, MODEL TRA-200, TRA-200-CP3, TRA-200-CP4	Oct 16, 2009	Substantially Equivalent	J. Morita USA, Inc.
K090548	CONTRA-ANGLE HANDPIECE KOMET OS30	Jun 30, 2009	Substantially Equivalent	W&H Dentalwerk Buermoos GmbH
K090369	PRODRIVE LINE OF DENTAL HANDPIECES	Feb 27, 2009	Substantially Equivalent	Prodrive Systems, Inc.
K083101	PREMIUM SLOW SPEED; 20K AIR MOTOR, HEADS, CONTRA-ANGLES, STRAIGHT NOSECONES	Feb 23, 2009	Substantially Equivalent	Sable Industries, Inc.
K082791	EMS AIR-FLOW MASTER	Feb 18, 2009	Substantially Equivalent	E.M.S Electro Medical Systems S.A
K081811	CARE3 PLUS	Jan 21, 2009	Substantially Equivalent	Nakanishi, Inc.
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	Jan 15, 2009	Substantially Equivalent	A-Dec, Inc.
K082827	A-DEC/W&H PROFIN RECIPROCATING CONTRA-ANGLE HANDPIECE ATTACHMENT	Jan 07, 2009	Substantially Equivalent	A-Dec, Inc.
K080682	HHC, SCORE, HENRY SCHEIN CANISTER HANDPIECE	Sep 11, 2008	Substantially Equivalent	Handpiece Headquarters, Inc. - Hpr, Inc.
K073478	SUPERTORQUE HIGH-SPEED HANDPIECES AND GENTLEPOWER HANDPIECES AND ATTACHEMENTS	Sep 03, 2008	Substantially Equivalent	Sybron Dental Specialties, Inc.
K073652	ND LOW SPEED AIRMOTOR AND HANDPIECE, HIGHSPEED AIRTURBINE HANDPIECE, E-TYPE STRAIGHT NOSECONE AND CONTRA ANGLE	Mar 20, 2008	Substantially Equivalent	Nakamura Magnifier Co., Ltd.
K080240	CHALLENGER/CLASSIC PUSH BUTTON HANDPIECE	Feb 07, 2008	Substantially Equivalent	Promident, LLC
K073319	STATMATIC 31 HANDPIECE MAINTENANCE UNIT	Feb 04, 2008	Substantially Equivalent	Scican , Ltd.
K072989	AXIS SYSTEM	Jan 28, 2008	Substantially Equivalent	Dentsply Intl., Inc.
K072754	AXENIC DHP DISPOSABLE HIGH-PERFORMANCE HANDPIECE	Jan 25, 2008	Substantially Equivalent	Axenic Dental, Inc.
K073284	AIR-FLOW MASTER STANDARD	Dec 14, 2007	Substantially Equivalent	(Ems Sa) Electro Medical Systems
K073353	DO-ALL DENTAL HANDPIECE LUBRICANT	Dec 07, 2007	Substantially Equivalent	Prodrive Systems, Inc.
K072554	ACCESS AND ROTAMAX FIBER OPTIC HIGH SPEED DENTAL HANDPIECES	Nov 14, 2007	Substantially Equivalent	Sable Industries, Inc.
K071561	HI-SPEED TURBINE HANDPIECES, MODEL GSO1-B,GSO2-B,GSO3-B,GSO1-D,GSO2-D	Oct 12, 2007	Substantially Equivalent	Beijing North Pole Dental Handpiece Co., Ltd.
K071891	STATIS DENTAL HANDPIECES	Sep 13, 2007	Substantially Equivalent	Scican , Ltd.
K071965	I-SURGE	Sep 10, 2007	Substantially Equivalent	Satelec
K070663	A-DEC/W&H SYNEA AIR-DRIVEN HIGHSPEED HANDPIECE, MODEL TA-98, TA-97, A-DEC/W&H SYNEA HANDPIECE ATTACHMENT	Jul 05, 2007	Substantially Equivalent	A-Dec, Inc.
K070869	PROPHY STAR 3 HYGIENE HANDPIECE, MODEL 264422	Jun 15, 2007	Substantially Equivalent	Dentalez, Inc.
K070074	LUBRINA, MODEL HIM-1	May 31, 2007	Substantially Equivalent	J. Morita USA, Inc.
K070297	CLEARVIEW DENTAL HANDPIECE LUBRICATOR AND LUBRICANT	Feb 05, 2007	Substantially Equivalent	Dental Air Solutions of Nc, Inc.
K070001	MASTER CLASSIC 5K LOW SPEED HANDPIECE, 20K LOW SPEED HANDPIECE, TM5 LOW SPEED HANDPIECE AND TM20 LOW SPEED HANDPIECE	Feb 02, 2007	Substantially Equivalent	Mti Precision Products
K070155	INTEGRITY LOW SPEED DENTAL AIR HANDPIECE AND ATTACHMENT, MODELS: MOTOR INT-E, MOTOR INT-D AND ATTACHMENT INT-SNC	Jan 25, 2007	Substantially Equivalent	Osseo Scientific, LLC
K062947	HIGH SPEED AIR TURBINE HANDPIECE, MODELS SUPER-AIR AND SUPER-QD SERIES	Dec 14, 2006	Substantially Equivalent	Peng Lim Enterprise Co., Ltd.
K062812	DENTAL AIR-POWERED HANDPIECE, MODELS TIGER 300T, 300K, 300W, 300B AND 300N	Nov 28, 2006	Substantially Equivalent	Thunder Tiger Corp.
K062740	JINDELL HIGH SPPED AIR TURBINE HANDPIECE, MODELS SW, SP, SU, ETU, MU	Nov 02, 2006	Substantially Equivalent	Jindell Medical Instruments Co., Ltd.
K063110	CST61 HIGH SPEED TURBINE HANDPIECE	Oct 26, 2006	Substantially Equivalent	Shanghai Dental Instrument Factory
K062418	K-SPRAY, MODEL 085-2715	Oct 19, 2006	Substantially Equivalent	Scican
K062219	PRODRIVE SYSTEMS REPLACEMENT TURBINE	Aug 04, 2006	Substantially Equivalent	Prodrive Systems, Inc.
K053368	INTERPROXIMAL REDUCTION SYSTEM	Mar 29, 2006	Substantially Equivalent	Dentsply International
K052822	DENTAL AIR-POWERED HANDPIECE, MODELS TIGER 100, 101, 200, 201 AND 202	Jan 20, 2006	Substantially Equivalent	Thunder Tiger Corp.
K052700	PANA-SPRAY	Dec 20, 2005	Substantially Equivalent	Nsk America Corp.
K051872	MK-DENT LOW SPEED HANDPIECES AND ACCESSORIES INCLUDING SPARE PARTS, TUBINGS, AND LIGHT POWER SYSTEM, MODELS: LS2011	Oct 03, 2005	Substantially Equivalent	Mk-Dent GmbH
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	Mar 21, 2005	Substantially Equivalent	J. Morita USA, Inc.
K043498	TWIN POWER TURBINE HIGH SPEED AIR TURBINE DENTAL HANDPIECE	Feb 16, 2005	Substantially Equivalent	J. Morita USA, Inc.
K042787	IS 40 MICROMOTOR	Dec 17, 2004	Substantially Equivalent	Satelec
K041755	CROMAX HIGH SPEED TURBINE HANDPIECE	Oct 22, 2004	Substantially Equivalent	J.R. Medical Technologies, Inc.
K041141	DENTSPLY CAVITRON JET WAVE AIR POLISHING PROPHYLAXIS SYSTEM, MODEL G125	Jun 16, 2004	Substantially Equivalent	Dentsply Intl.
K033812	SIROAIR L AIR SCALER	Feb 23, 2004	Substantially Equivalent	Sirona Dental Systems GmbH
K033213	CODENT DENTAL AIR-POWERED HANDPIECE, MODEL HPS	Feb 06, 2004	Substantially Equivalent	Codent Technical Industry Co., Ltd.
K032395	PROPHY-MATE	Oct 17, 2003	Substantially Equivalent	Nakanishi, Inc.
K032234	MK-DENT HIGH SPEED DENTAL HANDPIECE, MODELS HS 4021K, 4011K, 4012K, AND HS 6021K, 6011K, 6012K	Oct 02, 2003	Substantially Equivalent	Mk-Dent GmbH
K031851	DENTISEPTIC HPC	Aug 01, 2003	Substantially Equivalent	Bethel, Inc.
K031145	ESTYLUS ELECTRIC MOTOR SYSTEM	Jul 15, 2003	Substantially Equivalent	Dentsply Intl.
K031868	PROPHYPEARLS	Jul 09, 2003	Substantially Equivalent	Kavo America
K022535	MICROTECH PUSH BUTTON HANDPIECE, MODEL MHS-A100	Oct 22, 2002	Substantially Equivalent	Microtech
K022119	EMS AIR-FLOW HANDY 2 DENTAL HANDPIECE	Jul 25, 2002	Substantially Equivalent	Electro Medical Systems SA
K012308	KAVO QUATTROCARE	Jun 26, 2002	Substantially Equivalent	Kavo America
K012720	TULSA CONTRA ANGLES	Nov 08, 2001	Substantially Equivalent	Dentsply Intl.
K010127	W & H ASSISTINA	Oct 05, 2001	Substantially Equivalent	A-Dec, Inc.
K003518	RAPIDD HIGHSPEED DENTAL HANDPIECE	Jan 09, 2001	Substantially Equivalent	Dentsply Intl.
K000834	CASTELLNI AIR POWERED HANDPIECES SYRINGES: THREE STERIL, MULTISTERIL TURBINS: CLEANAIR, CLEANLIGHT MICROMOTORS: IMPLANTO	Dec 14, 2000	Substantially Equivalent	Castellini S.P.A.
K000848	TDK HANDPIECES	Oct 05, 2000	Substantially Equivalent	Orasystems
K000847	ORALUBE	Sep 27, 2000	Substantially Equivalent	Orasystems
K000710	MD 10, SEM, SM 12, CBM	May 11, 2000	Substantially Equivalent	NOUVAG AG
K000547	ATR TECNIKA	May 03, 2000	Substantially Equivalent	Advanced Technology Research (A.T.R.) S.R.P.
K000049	SUNI MAX	Apr 04, 2000	Substantially Equivalent	Satelec
K993526	SYNEA - LS LOW-SPEED HANDPIECE	Jan 11, 2000	Substantially Equivalent	A-Dec, Inc.
K971732	DENTAL HANDPIECE	Jan 11, 2000	Substantially Equivalent	Pauline M. Nicholls
K991401	ATR 3000, ATR 2000, IMPLANT-PRO	Dec 15, 1999	Substantially Equivalent	Advanced Technology Research (A.T.R.) S.R.P.
K991492	LC COMPOSITE	Dec 02, 1999	Substantially Equivalent	Harry J. Bosworth Co.
K992380	ENDO-EZE MOTOR AND HANDPIECE	Oct 13, 1999	Substantially Equivalent	Ultradent Products, Inc.
K991857	AIRFLOW HANDY	Oct 07, 1999	Substantially Equivalent	Electro Medical Systems, Inc.
K992011	SYNEA-HS HIGH SPEED-HANDPIECE	Sep 10, 1999	Substantially Equivalent	A-Dec, Inc.
K991701	MACH-SIGMA HANDPIECE, ULTRAPUSH, MODELS MACH-SIGMA MU (MINI HEAD), MACH-SIGMA SU (STD. HEAD), MACH-SIGMA TU (TORQUE HD)	Aug 10, 1999	Substantially Equivalent	Nsk Nakanishi, Inc.
K984244	ORL-E-92 SURGICAL DRILL SYSTEM	Feb 23, 1999	Substantially Equivalent	Bien Air USA, Inc.
K981679	TCM 3000 AND TCM ENDO	Feb 09, 1999	Substantially Equivalent	NOUVAG AG
K983183	GYRO LONG-LIFE,BLACK PEARL ECO, ONDINE &CROMA, PRESTIGE, BORA, AQUILON, MC2,MC3, BASCH, ISOLITE, OPTIMA, US, PLPE, CA, P	Dec 10, 1998	Substantially Equivalent	Bien Air USA, Inc.
K983168	AVANT HIGH SPEED HANDPIECE, AVANT FIBER OPTIC HIGH SPEED HANDPIECE, MODEL #'S AVANT HS 100 & AVANT HS 200	Nov 18, 1998	Substantially Equivalent	Ora Innovations, Inc.
K982593	LUBE FREE AUTOCHUCK TURBINE WITH VORTEX AIR SEAL FOR USE WITH STAR DENTAL 430 SERIES LUBE FREE HIGH SPEED DENTAL HANDPIE	Oct 22, 1998	Substantially Equivalent	Dentalez Group
K980585	MILLENNIUM	Oct 08, 1998	Substantially Equivalent	Biolase Technology, Inc.
K982050	MODEL MS-2 HANDPIECE	Sep 02, 1998	Substantially Equivalent	Parkell, Inc.
K981869	PRO-FLEX DISPOSABLE PROPHY ANGLE	Aug 11, 1998	Substantially Equivalent	Professional Dental Mfg., Inc.
K981990	MRS-400, MAXI 400, MRSL-400, MAXI 400L	Jun 22, 1998	Substantially Equivalent	D.B.I. America Corp.
K980162	MACH-SIGMA HANDPIECE, ULTRAPUSH	Jun 05, 1998	Substantially Equivalent	Nsk Nakanishi, Inc.
K974670	ATHENA 1:1 CONTRA ANGLE, ATHENA 4:1 CONTRA ANGLE, ATHENA 16:1 CONTRA ANGLE, ATHENA 64:1 CONTRA ANGLE, ATHENA 16-: CONTRE	Mar 13, 1998	Substantially Equivalent	Athena Technology, Inc.
K974671	ATHENA 20R S TYPE SLOW SPEED HANDPIECE MOTOR	Mar 11, 1998	Substantially Equivalent	Athena Technology, Inc.
K973876	PROPHYFLEX 2, MODEL 2012	Dec 19, 1997	Substantially Equivalent	Kavo America
K972436	T1 LINE DENTAL HANDPIECES	Sep 22, 1997	Substantially Equivalent	Siemens AG
K972376	IMPACT AIR 45 HANDPIECE FOR PERIODONTAL USE	Sep 10, 1997	Substantially Equivalent	Glenwood, LLC
K972375	IMPACT AIR 45 HANDPIECE FOR ENDODONTIC USE	Sep 10, 1997	Substantially Equivalent	Glenwood, LLC
K971774	NSK PUSH-BUTTON MIDWEST REPLACEMENT TURBINE:FOR QUIETAIR AND TRADITION	Jun 20, 1997	Substantially Equivalent	Nsk Nakanishi, Inc.
K970104	SANI-SHIELD	May 06, 1997	Substantially Equivalent	Dw Industries, Inc.
K963843	ELECTRIC SURGICAL IRRIGATION SYSTEM - DUAL CONTROLLER UNIT	Mar 31, 1997	Substantially Equivalent	Micro Motors, Inc.
K961275	SIRIUS 10, 10L, 40, 40L	Jan 17, 1997	Substantially Equivalent	Micro-Mega Societe Anonyme
K961235	SIRIUS 180, 180L, 230, 230L	Jan 08, 1997	Substantially Equivalent	Micro-Mega Societe Anonyme
K963664	DENTAL HANDPIECE AND ACCESSORY	Oct 24, 1996	Substantially Equivalent	Filmtech, Inc.
K962877	MIDWEST 300 SE	Oct 18, 1996	Substantially Equivalent	Midwest Dental Products Corp.
K963050	TRADITION P, PUSH BUTTON HANDPIECE	Oct 11, 1996	Substantially Equivalent	Midwest Dental Products Corp.
K962542	AIR MOTOR HANDPIECE TN-102	Sep 24, 1996	Substantially Equivalent	Nsk Nakanishi, Inc.
K962543	ALPHA AIR HANDPIECE, ULTRA-PUSH, AL-SU, AL-MU, AL-TU	Sep 11, 1996	Substantially Equivalent	Nsk Nakanishi, Inc.
K952927	IMPACT AIR 45 4-HOLE	Aug 06, 1996	Substantially Equivalent	Palisades Pharmaceutics, Inc.
K961076	MM 324	Apr 26, 1996	Substantially Equivalent	Micro-Mega Societe Anonyme
K961163	LARES RESEARCH AS-1 LOWSPEED HANDPIECE	Apr 23, 1996	Substantially Equivalent	Lares Research, Inc.
K960541	LYNX DPA DISPOSABLE PROPHY ANGLE	Mar 28, 1996	Substantially Equivalent	Mti Precision Products
K955655	MIDWEST ONE	Mar 05, 1996	Substantially Equivalent	Midwest Dental Products Corp.
K960352	ALLRAP/SLIP-N-GRIP	Feb 21, 1996	Substantially Equivalent	Dental Disposables Intl., Inc.
K955654	SHORTSTOP DISPOSABLE PROPHY ANGLE	Feb 08, 1996	Substantially Equivalent	Spintech, Inc.
K945256	MTC 7707 HIGH SPEED AIR TURBINE	Jan 29, 1996	Substantially Equivalent	Mtc Industries and Research, Ltd.
K954722	MICRO-DISPENSER 7000 & MICRODISPENSER 8000	Jan 16, 1996	Substantially Equivalent	NOUVAG AG
K954991	PHASE CHANGE DENTAL LUBRICANT	Jan 04, 1996	Substantially Equivalent	Phase Change
K954012	DISPOSABLE PROPHY HANDPIECE	Nov 08, 1995	Substantially Equivalent	Denticator Intl., Inc.
K945734	W&H ROTO QUICK COUPLINGS	Oct 05, 1995	Substantially Equivalent	A-Dec, Inc.
K944719	W&H 100 SERIES LOW SPEED	Oct 05, 1995	Substantially Equivalent	A-Dec, Inc.
K944718	W&H 900 INCOLIGHT LT HANDPIECE	Oct 05, 1995	Substantially Equivalent	A-Dec, Inc.
K944713	W&H MICRO AIR MOTOR LT25	Aug 28, 1995	Substantially Equivalent	A-Dec, Inc.
K944714	W&H CORSAIR SCALER	Aug 25, 1995	Substantially Equivalent	A-Dec, Inc.
K944712	W&H MICRO MOTOR E25 (WITHOUT LIGHT)	Aug 25, 1995	Substantially Equivalent	A-Dec, Inc.
K944711	W&H AIR MOTOR A25	Aug 25, 1995	Substantially Equivalent	A-Dec, Inc.
K932333	PROTECTORAL ULTRASONIC HANDPIECE PROCESSOR	Aug 15, 1995	Substantially Equivalent	Gull Laboratories, Inc.
K944709	W&H 896 TOP LIGH HIGHSPEED	Jun 08, 1995	Substantially Equivalent	A-Dec, Inc.
K944717	W&H 798 TOP AIR TURBINE TRIPLE SPRAY	Jun 02, 1995	Substantially Equivalent	A-Dec, Inc.
K944716	W&H 796 TOP AIR TURBINE MINI-HEAD	Jun 02, 1995	Substantially Equivalent	A-Dec, Inc.
K944715	W&H 795 TOP AIR TURBINE SINGLE SPRAY	Jun 02, 1995	Substantially Equivalent	A-Dec, Inc.
K944710	W&H 898 TOP LIGHT HIGHSPEED	Jun 02, 1995	Substantially Equivalent	A-Dec, Inc.
K944708	W&H 895 TOP LIGH HIGHSPEED FIBEROPTIC SINGLE SPRAY	Jun 02, 1995	Substantially Equivalent	A-Dec, Inc.
K935676	MICRO RSH HIGH SPEED HANDPIECE	Mar 31, 1995	Substantially Equivalent	Micro Motors, Inc.
K923780	DENTOOL	Mar 21, 1995	Substantially Equivalent	Dentool, Inc.
K940261	LYNX LOW-SPEED HANDPIECE	Dec 29, 1994	Substantially Equivalent	Mti Precision Products
K925678	ATHENA HIGH SPEED HANDPIECE	Dec 15, 1994	Substantially Equivalent	Athena Technology, Inc.
K942672	STERI-LUBE	Jul 06, 1994	Substantially Equivalent	Petroleum Products of America
K926155	CA AND ST	Mar 04, 1994	Substantially Equivalent	Dabi-Atlante America Corp.
K926154	HANDPIECE MODELS: MS-350;RS-350;N-270 AIR-MOTOR	Mar 04, 1994	Substantially Equivalent	Dabi-Atlante America Corp.
K925080	TEK-LUBE	Jan 31, 1994	Substantially Equivalent	Clinical Technology Corp.
K932990	ORAL-B DISPOSABLE PROPHY ANGLE W/PROPHY CUP	Sep 29, 1993	Substantially Equivalent	Oral-B Laboratories
K925739	HIGH SPEED DENTAL DRILL/HANDPIECE	Jul 22, 1993	Substantially Equivalent	Feather Touch, Inc.
K925378	STERI-SOL SOLUTION, MODIFICATION	Jul 22, 1993	Substantially Equivalent	Anodia Systems
K924089	OPTI-SHIELD	Mar 31, 1993	Substantially Equivalent	Fuji Optical Systems, Inc.
K922437	HANDPIECE MODELS MS-350, RS-350; AIR MOTOR N-270	Dec 21, 1992	Substantially Equivalent	Dabi-Atlante America Corp.
K923469	ORALSAFE	Oct 05, 1992	Substantially Equivalent	Oralsafe, Inc.
K921564	POLYCLEAN	Aug 10, 1992	Substantially Equivalent	Medical Polymers, Inc.
K912786	W-H TOPAIR DENTAL HANDPIECE	Jul 17, 1991	Substantially Equivalent	Sabra-The Dental Products Group
K911937	OSTEOMED IB DRILL	Jun 10, 1991	Substantially Equivalent	Osteomed Corp.
K911068	29540 DYNASURG ELECTRIC HANDPIECE AND IRR. SYSTEM	May 15, 1991	Substantially Equivalent	Micro Motors, Inc.
K905542	LARES APOLLO CS AND S HANDPIECE LIGHTING SYSTEMS	Mar 11, 1991	Substantially Equivalent	Lares Research, Inc.
K905541	LARES 757 WORKHORSE HIGHSPEED HANDPIECE	Mar 07, 1991	Substantially Equivalent	Lares Research, Inc.
K905155	HIGH SPEED CEREAMIC BEARING TURBINE HANDPIECES	Feb 13, 1991	Substantially Equivalent	Star Dental Mfg. Co.
K904671	QAR HANDPIECE	Dec 21, 1990	Substantially Equivalent	Collagen Corp.
K900798	LYNX LOW-SPEED HANDPIECE	Jun 27, 1990	Substantially Equivalent	Air Motors Technologies
K901239	TELEDYNE GETZ'S DISPOSABLE PROPHY ANGLE	May 15, 1990	Substantially Equivalent	Teledyne Getz
K900093	DISPOSA-SHIELD(TM) INFECTION CONTROL BARRIER	Apr 06, 1990	Substantially Equivalent	Dentsply Intl.
K897101	DISPOSABLE PROPHY ANGLE AND ACCESSORIES	Mar 14, 1990	Substantially Equivalent	Dentsply Intl.
K896878	HANDPIECE SYSTEM WITH MOTOR (SEVERAL MODELS)	Mar 08, 1990	Substantially Equivalent	Micro Motors, Inc.
K896879	ORAL SURGERY HANDPIECE AND ATTACHMENTS	Mar 07, 1990	Substantially Equivalent	Micro Motors, Inc.
K896877	DENTAL AIR MOTORS (SEVERAL MODELS)	Mar 07, 1990	Substantially Equivalent	Micro Motors, Inc.
K896876	DYNATORQ DENTAL HANDPIECE ATTACHMENTS	Mar 07, 1990	Substantially Equivalent	Micro Motors, Inc.
K896361	HANDPIECE FIBER OPTIC SYSTEM IMPROVEMENT FEATURE	Feb 02, 1990	Substantially Equivalent	Dentalez Group
K895736	LYNX-HIGH SPEED HANDPIECE	Dec 18, 1989	Substantially Equivalent	Mti Precision Products
K894606	MICRO-AIRE HIGH SPEED DRILL (2910-000)	Oct 13, 1989	Substantially Equivalent	Micro-Aire Surgical Instruments, Inc.
K885115	IMD 7GX	Jun 23, 1989	Substantially Equivalent	Medical Dental Technology Co.
K890433	IMPLANT PARALLELING DEVICE (I.P.D.)	Jun 16, 1989	Substantially Equivalent	J.E. Josephson, D.M.D.
K882491	CUTTING FLUID SYSTEM FOR DENTAL HIGH SPEED DRILLS	Aug 26, 1988	Substantially Equivalent	Steri-Sol, Inc.
K881985	CONTRA ANGLE HANDPIECE ATTACH. W/PROPHYLAXIS CUP	Jul 25, 1988	Substantially Equivalent	Denticator
K881974	PROFICIENT(TM) PROPHYLAXIS ANGLE	Jul 25, 1988	Substantially Equivalent	Block Drug Company, Inc.
K882135	AQUA DENT HANDPIECE EXTENSION AND AQUA DENT DISP.	Jun 22, 1988	Substantially Equivalent	Vita Dental Co.
K874294	AUTOCHUCK ATTACHMENT	Dec 29, 1987	Substantially Equivalent	Den-Tal-Ez Mfg Co., Inc.
K873209	PLAQUE-SWEEP	Aug 25, 1987	Substantially Equivalent	Dentsply Intl.
K863677	TRADITION HIGH SPEED HANDPIECE	Oct 06, 1986	Substantially Equivalent	Midwest
K854645	GOLD AIR, GOLD LIGHT	Mar 12, 1986	Substantially Equivalent	Alpine Dental Equipment Co.
K854697	TUBING HANDPIECE REPLACEMENT	Mar 06, 1986	Substantially Equivalent	Almore Intl., Inc.
K850597	MICRO-AIRE HIGH SPEED ORAL SURGERG DRILL	Mar 25, 1985	Substantially Equivalent	Micro-Aire Surgical Instruments, Inc.
K840690	DENTAL HANDPIECE	Apr 25, 1984	Substantially Equivalent	Pen-Med Technology, Inc.
K821715	AM-40 SYSTEM	Jun 25, 1982	Substantially Equivalent	American Midwest
K821484	DAWN LOW SPEED HANDPIECE SYSTEM	Jun 09, 1982	Substantially Equivalent	Young Dental Manufacturing Co. 1, LLC
K801535	LARES HANDPIECE OIL	Dec 16, 1980	Substantially Equivalent	Lares Manufacturing Co., Inc.
K801651	CUTTER JET	Aug 13, 1980	Substantially Equivalent	Cutter Laboratories, Inc.
K792304	MW-8000	Nov 27, 1979	Substantially Equivalent	Midwest
K792302	LS-100	Nov 27, 1979	Substantially Equivalent	Midwest
K790601	DENTAL HANDPIECE	May 31, 1979	Substantially Equivalent	Venture Technology, Inc.
K790113	MIDWEST 1000	Feb 26, 1979	Substantially Equivalent	Midwest
K781545	AIR POWERED DENTAL HANDPIECE	Nov 15, 1978	Substantially Equivalent	Promident Mfg., Ltd.
K780483	FIBER OPTIC HANDPIECE	Apr 28, 1978	Substantially Equivalent	Syntex Corp.
K780038	DENTAL HANDPIECE	Jan 20, 1978	Substantially Equivalent	Lares Manufacturing Co., Inc.
K772244	ILLUMINATED DENTAL HANDPIECE	Jan 20, 1978	Substantially Equivalent	Litton Dental Products
K760929	ACCUTORQ II	Nov 19, 1976	Substantially Equivalent	Ritter Co.
K760794	FIBER OPTICS HIGH SPEED HANDPIECE	Oct 20, 1976	Substantially Equivalent	Midwest
K760331	TURBINE, AIR DRIVEN HANDPIECE (2000)	Aug 11, 1976	Substantially Equivalent	Litton Dental Products