Product Code: EIA FDA class 1 21 CFR 872.6640

Unit, Operative Dental

Dental

The Operative Dental Unit is a comprehensive dental treatment station that integrates multiple functions including delivery of air, water, and suction; handpiece connections; instrument trays; and patient chair controls, providing the central workstation for dental procedures. It is classified as FDA Class 1 (lowest risk), subject only to general controls. The product code is EIA, regulated under 21 CFR 872.6640 in the Dental (DE) specialty. This device is eligible for third-party review.

View on FDA

510(k)s

284

FEI Numbers

111

Registration Numbers

111

Unique Applicants

193

Years Active

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Basic Information

Product Code: EIA
Device Class: FDA class 1
Regulation Number: 872.6640
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 284 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K251626	Midmark Dental Delivery System	Nov 03, 2025	Substantially Equivalent	Midmark Corporation
K251491	K5 Cart, K5 Mount, K5 Swing	Jul 17, 2025	Substantially Equivalent	Osstem Implant Company., Ltd. Chair Business
K243130	Integral Dental Unit	Jun 27, 2025	Substantially Equivalent	Guangdong Yadeng Medical Apparatus Co., Ltd.,
K242611	Integral Dental Units	May 27, 2025	Substantially Equivalent	Mipont Medical Equipment Co., Ltd.
K250473	Dental Delivery System Series 5 and Dental Delivery System Series 5 Plus	Feb 19, 2025	Substantially Equivalent	Dci International, LLC
K242404	BDC Dental Unit	Feb 07, 2025	Substantially Equivalent	Bdc Dental Corporation , Ltd.
K231297	Firstar Dental Unit	Jan 27, 2025	Substantially Equivalent	Firstar Dental Company
K233805	K5	Sep 03, 2024	Substantially Equivalent	Osstem Implant Co., Ltd. Chair Business
K240754	N2	Mar 21, 2024	Substantially Equivalent	Megagen Implant Co., Ltd.
K231845	Dental unit Model: Mare	Feb 28, 2024	Substantially Equivalent	Foshan Safety Medical Equipment Co., Ltd.
K202963	ELEC Master, ELEC Master Dual	May 05, 2023	Substantially Equivalent	Mgnewton , Ltd.
K211556	N2	Apr 05, 2023	Substantially Equivalent	Megagen Implant Co., Ltd.
K213749	G7, Dental Operative Unit and Accessories	Apr 03, 2023	Substantially Equivalent	Shinhung Company, Ltd.
K220873	Perceptive electric dental motor and control unit	Dec 15, 2022	Substantially Equivalent	Lares Research
K213742	Infinity Pro, Logic, Quality, Sprint	Oct 19, 2022	Substantially Equivalent	Olsen Indústria E Comércio S.A.
K213932	A-dec 300, A-dec 500	Mar 02, 2022	Substantially Equivalent	A-Dec, Inc.
K180935	Infinity / Infinity Cross Flex Dental Systems	Feb 05, 2020	Substantially Equivalent	Olsen Industria E Comercio S.A.
K183347	K3	Sep 04, 2019	Substantially Equivalent	Osstem Implant Co., Ltd.
K183121	Qraypen	Jul 18, 2019	Substantially Equivalent	AIOBIO Co., Ltd.
K173608	Forest Dental Unit	Aug 17, 2018	Substantially Equivalent	Forest Dental Products, Inc.
K171872	P50 Series Dental Operative Unit and Accessories	Apr 26, 2018	Substantially Equivalent	Pelton & Crane
K152830	K3	Apr 20, 2017	Substantially Equivalent	Osstem Implant Co., Ltd.
K161734	Vanguard Dental Unit	Dec 09, 2016	Substantially Equivalent	Ritter Concept GmbH
K161488	ESTETICA Dental Treatment Unit and Accessories	Dec 08, 2016	Substantially Equivalent	Kaltenbach & Voigt GmbH
K152100	Evogue Dental Unit	Jan 22, 2016	Substantially Equivalent	Takara Belmont Corporation
K151996	TAURUS C1	Jan 22, 2016	Substantially Equivalent	Shinhung Company, Ltd.
K143696	Spirit	Sep 18, 2015	Substantially Equivalent	Pelton & Crane
K151045	TENEO Dental Treatment Unit and Accessories	Jul 24, 2015	Substantially Equivalent	Sirona Dental Systems GmbH
K150909	INTEGO Family and Accesories	Jul 17, 2015	Substantially Equivalent	Sirona Dental Systems GmbH
K150490	UnicLine Mobile	Apr 17, 2015	Substantially Equivalent	Heka Dental A/S
K142206	Dental Unit	Mar 13, 2015	Substantially Equivalent	Zhuhai Siger Medical Equipment Co., Ltd.
K141504	T-8000 THEROZONE UNIT	Feb 24, 2015	Substantially Equivalent	Therozone USA, Inc.
K133412	S200, S300	Jan 08, 2015	Substantially Equivalent	Cefla S.C.
K132245	AJAX DENTAL UNIT	Sep 05, 2014	Substantially Equivalent	Pro Dental Services, LLC
K132315	ERGONOMIC PRODUCTS WORKSTATION	Apr 18, 2014	Substantially Equivalent	Ergonomic Products, Inc.
K130534	DIPLOMAT	Oct 30, 2013	Substantially Equivalent	Diplomat Dental S.R.O.
K130410	DENTAL UNIT WITH CHAIR	Jul 26, 2013	Substantially Equivalent	Xianyang North West Medical Instrument (Group) Co.
K120239	ELEVANCE	Aug 24, 2012	Substantially Equivalent	Midmark
K110481	TRITON SELF CONTAINED DENTAL SYSTEM, TRITON SELF CONTAINED DENTAL SYSTEM, WITH CASE	Apr 05, 2012	Substantially Equivalent	Asi Medical, Inc.
K111907	DYNAMIC DU SERIES PORTABLE DENTAL UNIT	Dec 02, 2011	Substantially Equivalent	Shanghai Dynamic Industry Co., Ltd.
K112321	CS 1200	Nov 10, 2011	Substantially Equivalent	Carestream Health, Inc.
K101332	AMC-20 PORTABLE DENTAL CART MODEL AMC-20	Apr 11, 2011	Substantially Equivalent	Aseptico, Inc.
K102223	CHALLENGE-EVER	Feb 25, 2011	Substantially Equivalent	Hallim Dentech Co., Ltd.
K103550	YOBOSHI DENTAL UNIT	Jan 04, 2011	Substantially Equivalent	Fosham Yoboshi Medical Equipment Co., Ltd.
K102234	A-DEC 200 DENTAL SYSTEM	Nov 24, 2010	Substantially Equivalent	A-Dec, Inc.
K100212	DENTACENTER/EXPEDITION, MODEL SAF-430	Oct 22, 2010	Substantially Equivalent	Safari Dental, Inc.
K092917	STERN'S S250 NORDAM	Jun 24, 2010	Substantially Equivalent	Cefla S.C.
K092851	MODEL GDCH-2000	Sep 29, 2009	Substantially Equivalent	Global Dental Direct, Inc.
K091186	KODAK 1500 INTRAORAL CAMERA	Aug 18, 2009	Substantially Equivalent	Carestream Health, Inc.
K090079	VIVID, MODELS 40-A0001, 40-A0004, 40-A0006	May 01, 2009	Substantially Equivalent	Progeny, Inc.
K082985	A-DEC 334/335 DELIVERY SYSTEM	Dec 17, 2008	Substantially Equivalent	A-Dec, Inc.
K081699	PLANMECA SOVEREIGN	Aug 29, 2008	Substantially Equivalent	Planmeca USA, Inc.
K081237	CRAFTMASTER CONTOUR EQUIPMENT, INC., VISTA MODEL V-20, SATELLITE MOBILE UNIT MODEL ST-98 AND SATELLITE UNIT	Aug 25, 2008	Substantially Equivalent	Craftmaster Contour Equipment, Inc.
K082294	WESTAR SERIES DENTAL UNITS	Aug 22, 2008	Substantially Equivalent	Westar Medical Products, Inc.
K080677	COMFORTRONIC 4894 AND COMFORTDRIVE 200XDA HANDPIECE	Jun 06, 2008	Substantially Equivalent	Kaltenbach & Voigt GmbH & Co.
K080438	DENTAL UNIT WITH CHAIR	Apr 04, 2008	Substantially Equivalent	North West Medical Instrument (Group) Co., Ltd.
K071485	TPC ADVANCECAM INTRA ORAL CAMERA SYSTEM, MODEL AIC 888	Aug 28, 2007	Substantially Equivalent	Tpc Advanced Technology, Inc.
K063646	OPTI	Mar 07, 2007	Substantially Equivalent	Camsight Co., Inc.
K070196	FLIGHT DENTAL SYSTEMS A-SERIES DENTAL OPERATIVE UNIT	Jan 26, 2007	Substantially Equivalent	Hr Dental Products, Inc.
K062897	C-U2	Dec 14, 2006	Substantially Equivalent	Cefla S.C.R.L.
K063302	SDIF DENTAL CHAIR WITH OPERATIVE UNIT AND ACCESSORIES	Nov 15, 2006	Substantially Equivalent	Shanghai Dental Instrument Factory
K052574	COMPACT PLUS - EXTREME - PERFECT PLUS	Jul 17, 2006	Substantially Equivalent	J.O. Suarez & Cia, Ltda
K061175	CLARIS I310D INTRAORAL CAMERA SYSTEM & ACCESSORIES	May 23, 2006	Substantially Equivalent	Sota Precision Optics, Inc.
K050571	ABSOLUTE AMERICA	Nov 02, 2005	Substantially Equivalent	Eurodent S.P.A.
K052470	F1 SERIES DENTAL CHAIRS WITH OPERATIVE UNIT	Nov 01, 2005	Substantially Equivalent	Shanghai Fimet Medical Instrument Co., Ltd.
K051657	A-DEC SELF-CONTAINED WATER SYSTEM	Aug 30, 2005	Substantially Equivalent	A-Dec, Inc.
K050201	AEU-14CF EXPENDITION	Mar 18, 2005	Substantially Equivalent	Aseptico, Inc.
K043496	SPACELINE EMCIA, MODEL CU580	Feb 16, 2005	Substantially Equivalent	J. Morita USA, Inc.
K043325	ZOOMCAM LD-10 INTRAORAL CAMERA AND ACCESSORIES	Feb 11, 2005	Substantially Equivalent	Rolence Enteprise, Inc.
K042759	OPTIMA MX	Oct 20, 2004	Substantially Equivalent	Bien-Air SA Switzerland
K041805	MICROSCOPE SYSTEM	Sep 21, 2004	Substantially Equivalent	Miras Mirror Imaging Solutions, Ltd.
K041458	MARE DENTAL OPERATIVE UNIT	Aug 24, 2004	Substantially Equivalent	Denimed Electronica S.H.
K040529	COCOON HYGIENIST	Aug 19, 2004	Substantially Equivalent	Satelec
K040117	UNIPORT SELF-CONTAINED PORTABLE DENTAL UNIT	Apr 21, 2004	Substantially Equivalent	Arrow Industries, LLC
K040116	HAWK INTRAORAL CAMERA AND ACCESSORIES	Apr 20, 2004	Substantially Equivalent	Dxm Co., Ltd.
K033925	BIOFREE	Apr 07, 2004	Substantially Equivalent	Dental Components, Inc.
K040691	INTRA ORAL CAMERA SYSTEM & ACCESSORIES, MODEL WIN-100D	Mar 23, 2004	Substantially Equivalent	Win-Us Technology Co., Ltd.
K033419	STV PRO 2	Feb 02, 2004	Substantially Equivalent	Trophy Radiologie
K032757	A-DEC SELF-CONTAINED WATER SYSTEM, MODEL 0.7 LITER BOTTLE & 2 LITER BOTTLE	Dec 10, 2003	Substantially Equivalent	A-Dec, Inc.
K032756	A-DEC 532/533 DELIVERY SYSTEM MODEL, 532/533	Dec 04, 2003	Substantially Equivalent	A-Dec, Inc.
K032543	SIRONA DENTAL SYSTEMS C8+DENTAL OPERATIVE UNIT WITH ACCESSORIES	Nov 14, 2003	Substantially Equivalent	Sirona Dental Systems GmbH
K031681	STERISIL ANTIMICROBIAL TUBING AND BOTTLE	Oct 30, 2003	Substantially Equivalent	Sterisil
K032904	ACUCAM CONCEPT IV FWT, MODEL 110-0185G1	Oct 14, 2003	Substantially Equivalent	Dentsply Intl.
K032070	ELCACAM	Aug 27, 2003	Substantially Equivalent	A-Dec, Inc.
K032341	INTRA ORAL CAMERA SYSTEM AND ACCESSORIES, MODEL CLARIS I310	Aug 25, 2003	Substantially Equivalent	Sota Precision Optics, Inc.
K023896	C-1890	Jun 19, 2003	Substantially Equivalent	Anodia Systems
K023815	C-1805M	Jun 19, 2003	Substantially Equivalent	Anodia Systems
K023513	LOGOS JUNIOR DENTAL CHAIR AND UNIT	Mar 26, 2003	Substantially Equivalent	Castellini S.P.A.
K023213	RDH-2000	Jan 16, 2003	Substantially Equivalent	Anodia Systems
K022217	AEU-425 TRANSPORT II PORTABLE DENTAL SYSTEM	Oct 24, 2002	Substantially Equivalent	Aseptico, Inc.
K021083	VERACAM	Aug 30, 2002	Substantially Equivalent	Lumalite, Inc.
K020833	BOYD DELIVERY UNIT	Aug 08, 2002	Substantially Equivalent	Boyd Industries, Inc.
K020957	ORACAM	Jun 13, 2002	Substantially Equivalent	Video Dental Concepts, Inc.
K020206	INTRAORAL CAMERA ME-15	Apr 11, 2002	Substantially Equivalent	Dent Corp. Research & Development
K013690	IDENT-A100 INTRAORAL VIDEO CAMERA	Jan 30, 2002	Substantially Equivalent	Confident Technology, Inc.
K012744	INTRAORAL LENS OPTION TO SPECTROSHADE	Jan 23, 2002	Substantially Equivalent	Mht Optic Research AG
K012505	SOPRO595 INTRA ORAL CAMERA	Oct 05, 2001	Substantially Equivalent	Sopro
K012213	GULLIVER AND CLASSE A	Aug 13, 2001	Substantially Equivalent	American Dental Technologies, Inc.
K011222	PORTABELL, MODEL 4200	Jun 25, 2001	Substantially Equivalent	Bell Dental Products, LLC
K003265	CLEANAIR/ CLEANWATER UNIT, MODEL 1600	Dec 22, 2000	Substantially Equivalent	Texas Institute For Conservative Dentistry
K002620	SURESMILE SYSTEM	Nov 16, 2000	Substantially Equivalent	Orametrix, Inc.
K003090	MIDMARK PROCENTER INSTRUMENT DELIVERY SYSTEM	Oct 18, 2000	Substantially Equivalent	Midmark Corp.
K001878	WATER PURIFIER	Aug 03, 2000	Substantially Equivalent	Waterclave, LLC
K001445	SMILIE PC	Jul 26, 2000	Substantially Equivalent	Julie Alliance
K001541	MINICAM	Jul 21, 2000	Substantially Equivalent	Video Dental Concepts, Inc.
K000837	PUMA DENTAL CHAIR AND UNIT	Jul 11, 2000	Substantially Equivalent	Castellini S.P.A.
K000799	BELMONT UNIT, MODEL 2000 SERIES	May 17, 2000	Substantially Equivalent	Belmont Equipment Corp.
K000577	YOSHIDA WAVE PICT CAM INTRAORAL CAMERA, SIGMA BIOMEDICS SIGMACAM INTRAORAL CAMERA	May 05, 2000	Substantially Equivalent	The Yoshida Dental Mfg. Co., Ltd.
K000968	3181 DUO DELIVERY SYSTEM	May 03, 2000	Substantially Equivalent	A-Dec, Inc.
K000967	4635 ASSISTANT'S INSTRUMENTATION	May 03, 2000	Substantially Equivalent	A-Dec, Inc.
K000966	4631 DUO DELIVERY SYSTEM	May 03, 2000	Substantially Equivalent	A-Dec, Inc.
K000112	ACUCAM CONCEPT IV, MODELS A1222B, A1223B, A1221B, A1121B, A1222C, A10402, A10403, A10401	Apr 13, 2000	Substantially Equivalent	Dentsply Intl.
K000941	STERLTECH WATER PURIFIER	Apr 06, 2000	Substantially Equivalent	Sterltech, Inc.
K992195	QUANTEC-E IRRIGATION SYSTEM 2	Oct 08, 1999	Substantially Equivalent	Sybron Dental Specialties, Inc.
K992893	DENTAPURE DP 90 CARTRIDGE, DENTAPURE DP 365 CARTRIDGE	Sep 08, 1999	Substantially Equivalent	Mrlb Intl., Inc.
K992868	DENTAPURE DP40 CARTRIDGE	Sep 07, 1999	Substantially Equivalent	Mrlb Intl., Inc.
K991946	ULTRA-KLEEN POWDER FOR DENTAL UNIT WATER LINES, MODELS 513P, 505L	Sep 03, 1999	Substantially Equivalent	Sterilex Corp.
K991098	DIFOTI SYSTEM	Jun 30, 1999	Substantially Equivalent	Electro-Optical Sciences, Inc.
K991035	QUANTEC-E IRRIGATION SYSTEM	Jun 24, 1999	Substantially Equivalent	Sybron Dental Specialties, Inc.
K991011	ORASCOPE	Jun 23, 1999	Substantially Equivalent	Fiberdent Corp.
K990844	STARDENTAL AXCS STERILE WATER SYSTEM	May 28, 1999	Substantially Equivalent	Dentalez Group
K990479	HYGENICLEAR WKR 1, WATER-DELIVERY DEVICE ULTRACLEAR	May 13, 1999	Substantially Equivalent	Hygenitek, Inc.
K991161	HYDRO-CAST ACRYLIC VARNISH, MODEL 78125	Apr 29, 1999	Substantially Equivalent	Kay See Dental Mfg. Co.
K984332	SPECTRA VU 1000 SERIES INTRAORAL CAMERA, SPECTRA VU 2000 SERIES INTRAORAL CAMERA, SPECTRA VU HDDI SV I INTRAORAL CAMERA,	Apr 29, 1999	Substantially Equivalent	International Technology Concepts
K990948	S575 INTRAORAL DOCKING DENTAL CAMERA	Apr 21, 1999	Substantially Equivalent	Sopro
K984641	FLEXISCOPE OPTOMODUL	Mar 29, 1999	Substantially Equivalent	Schoelly Fiberoptic GmbH
K984584	AIR TECHNIQUES' DENTO-VAC	Mar 22, 1999	Substantially Equivalent	Air Techniques, Inc.
K984609	ADEC DENTAL UNIT, MODELS CENTURY PLUS & CASCADE, DCI DENTAL UNIT, MODEL SERIES III	Feb 09, 1999	Substantially Equivalent	Lite Specialty Metal Works, Inc.
K984556	SCICAN CLASSIC	Feb 09, 1999	Substantially Equivalent	Scholly Fiberoptic GmbH
K984013	PLANMECA INTRACAM STATION	Jan 26, 1999	Substantially Equivalent	Planmeca Oy
K983739	OPTUM, INTRAORAL CAMERA SYSTEM	Jan 19, 1999	Substantially Equivalent	Camsight, Inc.
K983661	BELMONT UNIT, MODEL 6000 SERIES AND 7500 SERIES	Jan 12, 1999	Substantially Equivalent	Belmont Equipment Corp.
K983625	S555 INTRAORAL DENTAL CAMERA	Jan 11, 1999	Substantially Equivalent	Sopro
K983735	PALL DENTAL FILTRATION SYSTEM WITH AIR WATER SYRINGE HOUSING AND FILTER MEMBRANE	Jan 07, 1999	Substantially Equivalent	Pall Medical
K983731	PALL DENTAL FILTRATION SYSTEM WITH INLINE HANDPIECE HOUSING AND FILTER MEMBRANE	Dec 21, 1998	Substantially Equivalent	Pall Medical
K983242	SIRONA C8 DENTAL OPERATIVE UNIT WITH ACCESSORIES	Dec 11, 1998	Substantially Equivalent	Sirona Dental Systems GmbH
K981171	ERADIC-ALL	Dec 02, 1998	Substantially Equivalent	Theratechnologies, Inc.
K983847	MODIFICATION OF: ODYSSEY I DENTAL WATER UNIT	Dec 01, 1998	Substantially Equivalent	Germiphene Corp.
K983285	ENGLE DENTAL FAMILY OF DELIVERY SYSTEMS	Nov 04, 1998	Substantially Equivalent	Engle Dental Systems
K973765	BIO-2000	Nov 04, 1998	Substantially Equivalent	Micrylium Laboratories
K982658	KSEA ENDOSCOPES FOR DENTAL PROCEDURES	Oct 15, 1998	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.
K981565	BIOCLEAR CONCENTRATE	Oct 15, 1998	Substantially Equivalent	Waggoner Product Development
K973410	ULTRACAM	Oct 08, 1998	Substantially Equivalent	W. Edward Johansen
K982480	PERIOVIEW MODEL DV-1 FIBERSCOPE AND WINDOW SHEATH.	Sep 15, 1998	Substantially Equivalent	Dentalview, Inc.
K981144	CLEAN SOURCE I, MODEL CS1000	Sep 15, 1998	Substantially Equivalent	Aquarius Technologies, Inc.
K982117	FLUID CONTROL	Sep 04, 1998	Substantially Equivalent	T.A. Coleman Ent.
K981937	WELCH ALLYN REVEAL INTRAORAL CAMERA SYSTEM	Aug 24, 1998	Substantially Equivalent	Welch Allyn, Inc.
K980049	BONETRAP	Aug 11, 1998	Substantially Equivalent	Bladhs Plast AB
K981663	DIGITAL DOC	Aug 10, 1998	Substantially Equivalent	Digital Doc, LLC
K980106	THE PROMA PERCEPTION, RESPONSE AND COMPASS SYSTEM AND ACCESSORIES	Aug 03, 1998	Substantially Equivalent	Proma, Inc.
K981534	VIPERCAM	Jul 23, 1998	Substantially Equivalent	Integra Medical
K982009	ONE WEEK BACKSTOP DENTAL ANTI-RETRACTION CHECK VALVE	Jun 25, 1998	Substantially Equivalent	Scitech Solutions, Inc.
K980577	PRINCESS SYRINGE	May 08, 1998	Substantially Equivalent	Sodexco
K980474	TELICAM	Apr 13, 1998	Substantially Equivalent	Dental/Medical Diagnostic Systems, Inc.
K974487	SEAC ADVANCED DENTAL SYSTEM - MODEL 2001,2010 OR MODEL 2020	Feb 18, 1998	Substantially Equivalent	Asi Medical, Inc.
K974542	TRUE VISION, TRUE VISION II	Feb 17, 1998	Substantially Equivalent	Medical Dynamics, Inc.
K974238	DENTAL TRAY, STERILE, DISPOSABLE	Feb 04, 1998	Substantially Equivalent	Trinity Laboratories, Inc.
K973996	CLEARLINE PLUS, DENTAL WATERLINE FILTER	Feb 04, 1998	Substantially Equivalent	Scitech Solutions, Inc.
K974204	VISTACAM OMNI AND VIASTCAM OMNI (IC)	Jan 08, 1998	Substantially Equivalent	Air Techniques, Inc.
K964271	IGN 500 TM WATER CLEANING UNIT WITH CALBENIUM LIQUID	Dec 19, 1997	Substantially Equivalent	Airel-West
K973492	DENTALVIEW PERIOVIEW SYSTEM	Oct 21, 1997	Substantially Equivalent	Dentalview, Inc.
K973035	VIOLA II DENTAL CAMERA SYSTEM	Sep 24, 1997	Substantially Equivalent	Innovative Medical Systems, Inc.
K971727	DCI WATER PURIFIER	Sep 12, 1997	Substantially Equivalent	Dental Components, Inc.
K972019	PEFECT SHOT	Jul 03, 1997	Substantially Equivalent	International Imaging Electronics
K971278	PURE COMPANY FLUID DELIVERY SYSTEM	Jul 03, 1997	Substantially Equivalent	Pure Co.
K972033	PLANMECA INTRACAM	Jun 20, 1997	Substantially Equivalent	Planmeca Oy
K964942	INFECTION CONTROL CARTRIDGE	Jun 19, 1997	Substantially Equivalent	Dentalpure Corp.
K971100	ATRION MEDICAL AUTOGENOUS TISSUE COLLECTOR	May 23, 1997	Substantially Equivalent	Atrion Medical Products, Inc.
K964796	ODYSSEY I DENTAL WATER UNIT	May 14, 1997	Substantially Equivalent	Germiphene Corp.
K970626	EASY CAM	Apr 04, 1997	Substantially Equivalent	I.C.S.
K970002	STERILE WATER PUMP	Mar 05, 1997	Substantially Equivalent	Micro Motors, Inc.
K964619	DELIVERY SYSTEM(SDS 1400 XL)/DELIVERY SYSTEM CUSPIDOR(SDS1450,SDS1650 XL)	Jan 22, 1997	Substantially Equivalent	Sds Dental, Inc.
K963548	DENTAPURE DENTAL UNIT WATER LINE FILTER-IODINATED	Jan 22, 1997	Substantially Equivalent	Mrlb Intl., Inc.
K963778	CDR-CAM	Nov 22, 1996	Substantially Equivalent	Schick Technologies, Inc.
K961420	PROSTYLE COMPACT	Sep 10, 1996	Substantially Equivalent	Planmeca Oy
K962665	A-DEC SELF-CONTAINED WATER SYSTEM	Aug 22, 1996	Substantially Equivalent	A-Dec, Inc.
K962071	SPIRIT S1/S2	Aug 06, 1996	Substantially Equivalent	Pelton & Crane Co.
K962527	GENERAL PURPOSE DENTAL TRAY	Aug 01, 1996	Substantially Equivalent	Medcare Medical Group, Inc.
K961409	PORTA'PURE/DENTAL	Jun 12, 1996	Substantially Equivalent	Water Solution Technologies
K960556	BACSTOP DENTAL ANTI-RETRACTION CHECK VALVE	May 08, 1996	Substantially Equivalent	Scitech Solutions, Inc.
K954471	POWERS ANTI-BACTERIAL VALVE	Apr 15, 1996	Substantially Equivalent	Powers Dental & Medical Technology, Inc.
K960506	A-DEC PERFORMER CONTROL UNIT	Mar 25, 1996	Substantially Equivalent	A-Dec, Inc.
K953912	JACOBYSCOPE	Nov 15, 1995	Substantially Equivalent	Perioview, Inc.
K951074	STOMAVISION (STV)	Sep 19, 1995	Substantially Equivalent	Trophy Radiologie
K951238	SAFE-TIPS EZ	May 23, 1995	Substantially Equivalent	Safe Wave Products, Inc.
K951019	INTRAORAL VIDEO SCOPE AND WINDOW TUBE	May 10, 1995	Substantially Equivalent	Cuda Products Co.
K950175	THE AQUA-AIR PROFESSIONAL FIELD UNIT(S)	Apr 18, 1995	Substantially Equivalent	Aqua-Air Medical Devices, Inc.
K942698	VACSTAR	Mar 17, 1995	Substantially Equivalent	Air Techniques, Inc.
K943204	VISTACAM	Mar 16, 1995	Substantially Equivalent	Air Techniques, Inc.
K946187	SPIRIT II AND SPIRIT TREATMENT CENTER	Mar 01, 1995	Substantially Equivalent	Pelton & Crane Co.
K944271	DENTAL OPERATIVE UNIT ACCESORIES	Dec 29, 1994	Substantially Equivalent	Dci Intl.
K944256	OKTAS INTRA-ORAL DENTAL CAMERA	Nov 22, 1994	Substantially Equivalent	Oktas
K942520	E-VAC-U-ACCESSORIES	Sep 09, 1994	Substantially Equivalent	Bull Frog Mfg. Co.
K941476	MODEL 2600 PROCART	Sep 02, 1994	Substantially Equivalent	Compressor Technologies, Ltd.
K941716	MICRODONTIC LENS	Aug 10, 1994	Substantially Equivalent	New Image Industries, Inc.
K940864	DENTIST WITH ASSISTANT PACK	Aug 02, 1994	Substantially Equivalent	Sterile Concepts, Inc.
K941349	DENTAL TRAY	Jul 26, 1994	Substantially Equivalent for Some Indications	Cush Medical Products
K934500	METASYS AMALGAM SEPARATOR MST1	Jul 13, 1994	Substantially Equivalent	Metasys Dental Products, Inc.
K940893	A-DEC RADIUS 2122/2132	Jul 12, 1994	Substantially Equivalent	A-Dec, Inc.
K941452	ULTRACAM II	Jun 10, 1994	Substantially Equivalent	Dental Vision Direct, Inc.
K934436	SBP DENTAL UNIT	Jun 02, 1994	Substantially Equivalent	Northland Dental Engineering
K934783	KAVO INTRASEPT 905	May 16, 1994	Substantially Equivalent	Kavo America
K940599	DUAL AIR/WATER FILTER CARTRIDGE HANDLE KIT	Apr 29, 1994	Substantially Equivalent	Q. C. Filter, Inc.
K935325	A-DEC CASCADE 3072 WALLMOUNT	Apr 21, 1994	Substantially Equivalent	A-Dec, Inc.
K933671	ULTRACAM	Mar 31, 1994	Substantially Equivalent	Dental Vision Direct, Inc.
K932873	SEAC MOBILE UNIT BY ASI MEDICAL	Mar 07, 1994	Substantially Equivalent	Asi Medical, Inc.
K930144	THE SCITECH ONE-DAY FILTER	Feb 22, 1994	Substantially Equivalent	Scitech Solutions, Inc.
K934002	PERIO/ENDO LENS	Feb 04, 1994	Substantially Equivalent	New Image Industries, Inc.
K934815	AIR COMPRESSOR, MODEL PAC 6.7	Feb 01, 1994	Substantially Equivalent	Defiance Electronics, Inc.
K931093	QUICK-CONNECT 360 SWIVEL TIP AUTOCLAVABLE SYRINGE	Jan 21, 1994	Substantially Equivalent	Dentalez Group
K922652	ACE BASIC DENTAL IMPLANT PACK I	Jan 10, 1994	Substantially Equivalent	Ace Surgical Supply Co., Inc.
K922651	ACE DENTAL IMPLANT KIT	Jan 10, 1994	Substantially Equivalent	Ace Surgical Supply Co., Inc.
K922650	ACE DENTAL IMPLANT CUSTOM SURGICAL PACK	Jan 10, 1994	Substantially Equivalent	Ace Surgical Supply Co., Inc.
K922649	ACE BASIC DENTAL IMPLANT PACK II	Jan 10, 1994	Substantially Equivalent	Ace Surgical Supply Co., Inc.
K932878	PRECISION INTRA-ORAL SCOPES	Jan 06, 1994	Substantially Equivalent	Precise Optics
K925798	A-DEC 2545 DUO IC MICRO-CART	Jan 06, 1994	Substantially Equivalent	A-Dec, Inc.
K925797	A-DEC 2544 DOCTORS IC MICRO-CART	Jan 06, 1994	Substantially Equivalent	A-Dec, Inc.
K933166	A-DEC 2611 ASSISTANT'S CART	Oct 20, 1993	Substantially Equivalent	A-Dec, Inc.
K933167	A-DEC 2912 DUO CART	Oct 13, 1993	Substantially Equivalent	A-Dec, Inc.
K933168	A-DEC 3127 ASSISTANT'S WALLMOUNT	Oct 12, 1993	Substantially Equivalent	A-Dec, Inc.
K933165	A-DEC 3131 DUO WALLMOUNT (WITH INSTRUMENTATION)	Oct 12, 1993	Substantially Equivalent	A-Dec, Inc.
K933163	A-DEC 2612 ASSISTANT'S CART	Oct 12, 1993	Substantially Equivalent	A-Dec, Inc.
K923354	PORT OPII, PORT OPIII	Oct 05, 1993	Substantially Equivalent	Mobile Dental Equipment Corp.
K932824	EVACUATOR, ORAL CAVITY	Sep 28, 1993	Substantially Equivalent	Den-Tal-Ez Mfg Co., Inc.
K922942	PRO-SCOPE MODEL # PS-4000	Sep 10, 1993	Substantially Equivalent	Pro-Den Systems, Inc.
K925967	MEDCAM	Aug 24, 1993	Substantially Equivalent	Medcam USA, Inc.
K931204	AS3000 OPERATIVE DENTAL UNIT (DELIVERY SYSTEM)	Jul 08, 1993	Substantially Equivalent	Den-Tal-Ez Mfg Co., Inc.
K922985	CLEAN UP	May 27, 1993	Substantially Equivalent	Bio-Probe, Inc.
K925829	WAGGONER DENTAL MANUFACTURING STERIWATER SYSTEM	Feb 12, 1993	Substantially Equivalent	Waggoner Dental Mfg.
K920710	AIR MEDICA III	May 04, 1992	Substantially Equivalent	Hinatawada Seimitsu Mfg. Co., Ltd.
K915353	MATRX MEDICAL MAXIMIZER 1000 AND 2000 VACUUM PUMP	Dec 27, 1991	Substantially Equivalent	Matrix Medica, Inc.
K914697	MDT/CASTLE PURUS DENTAL UNIT	Nov 13, 1991	Substantially Equivalent	Mdt Corp., Inc.
K913464	STOMAVISION (STV)	Nov 13, 1991	Substantially Equivalent	Trophy Radiologie
K911594	ORALCAM	Jul 03, 1991	Substantially Equivalent	Charmac Group, Inc.
K911506	MODEL 2100 PORTABLE FIELD UNIT	Jun 24, 1991	Substantially Equivalent	Dntl Corp.
K905401	ASEPTIMINI UNIT, ADU-10	Feb 20, 1991	Substantially Equivalent	Aseptico, Inc.
K905011	ORAL PHARYNGEAL CLEANSING DEVICE	Jan 31, 1991	Substantially Equivalent	Concord/Portex
K904948	PM2002 CC AND PM2002 EC	Jan 30, 1991	Substantially Equivalent	Planmeca USA, Inc.
K903455	A-DEC DECADE CUSPIDOR	Oct 24, 1990	Substantially Equivalent	A-Dec, Inc.
K903453	A-DEC IC MICRO-CART	Oct 24, 1990	Substantially Equivalent	A-Dec, Inc.
K903452	A-DEC IC CONTROL HEAD	Oct 24, 1990	Substantially Equivalent	A-Dec, Inc.
K903451	A-DEC PAC I PORTABLE UNIT	Oct 24, 1990	Substantially Equivalent	A-Dec, Inc.
K901806	SUCTION ORA-SWAB(R) BRUSH KIT	Aug 15, 1990	Unknown	Sage Products, Inc.
K901672	RESUBMITTED WATER PURIFIER FOR USE W/DENTAL TREAT	Jul 06, 1990	Substantially Equivalent	Pelton & Crane Co.
K896532	DENTAL DELIVERY SYSTEM	Feb 12, 1990	Substantially Equivalent	Dentech Corp.
K895877	RAMCLEAN DENTAL VACUUM LINE CLEANER	Dec 26, 1989	Substantially Equivalent	Ramvac Corp.
K895876	RAMVAC DENTAL VACUUM SYSTEM	Dec 26, 1989	Substantially Equivalent	Ramvac Corp.
K894058	ISODENT	Dec 21, 1989	Substantially Equivalent	Eurodent, Inc.
K894061	STUDIO UNO	Nov 21, 1989	Substantially Equivalent	Eurodent, Inc.
K894759	ALLPAC(TM) MATERIAL	Oct 13, 1989	Substantially Equivalent	Barrier Concepts, Inc.
K893219	MATRX DENTAL UNIT	Aug 07, 1989	Substantially Equivalent	Matrix Medica, Inc.
K891006	QUICK-TIP (DENTAL OPERATORY UNIT)	May 24, 1989	Substantially Equivalent	Bernard S Esrock
K884219	BRACKET TABLE ARM COVER	Mar 17, 1989	Substantially Equivalent	Steri-Shield Products, Inc.
K885299	SANI-SLEEVE DRAPE FOR DENTAL USE	Mar 16, 1989	Substantially Equivalent	Nieusma R & D, Inc.
K882526	DELIVERY PUMP FOR STERILE IRRIGANT & HANDPIECE DR.	Dec 08, 1988	Substantially Equivalent	Aseptico, Inc.
K883904	APOLLO VS, VT, VR 1000/1500, FREEDOM HS, HT, HR	Dec 07, 1988	Substantially Equivalent	Apollo Dental Products, Inc.
K883775	PORTABLE II DENTAL DELIVERY SYSTEM	Oct 14, 1988	Substantially Equivalent	Dntl Corp.
K882810	EASY-OP, PORTABLE DENTAL CART	Aug 12, 1988	Substantially Equivalent	Wy'East Medical Corp.
K861601	DP32 HAND HELD DENTAL PROPHYLAXIS UNIT	Oct 17, 1986	Substantially Equivalent	Stewart J. Lustgarten
K863021	CM-II, CM-I WATER UNIT	Oct 01, 1986	Substantially Equivalent	Sds Dental, Inc.
K863010	EUROCART SR-4, EUROCART M-IV, ISOCART III	Sep 26, 1986	Substantially Equivalent	Sds Dental, Inc.
K863023	CABINET II AUXILIARY UNIT	Sep 25, 1986	Substantially Equivalent	Sds Dental, Inc.
K854643	SOLAR	Mar 14, 1986	Substantially Equivalent	Alpine Dental Equipment Co.
K854642	SOLAR CART	Mar 14, 1986	Substantially Equivalent	Alpine Dental Equipment Co.
K854641	SOLAR F	Mar 10, 1986	Substantially Equivalent	Alpine Dental Equipment Co.
K852816	FREEDOM LINE LUBRICATED MODELS LS-2-5, LT-6-10	Oct 24, 1985	Substantially Equivalent	Apollo Dental Products, Inc.
K852524	SATALEC SERVOTORQUE S2 SX2	Jul 31, 1985	Substantially Equivalent	Spelna, Inc.
K851136	TROPHY COMPACT - DENTAL UNIT	Jul 31, 1985	Substantially Equivalent	Trophy Radiologie
K842357	PM 2000 DENTAL UNIT	Sep 12, 1984	Substantially Equivalent	Planmeca USA, Inc.
K832673	SATELEC PROPHY UNIT PU-2000	Oct 19, 1983	Substantially Equivalent	Spelna, Inc.
K823230	STERILE WATER SYSTEM	Dec 03, 1982	Substantially Equivalent	Syntex Dental Products, Inc.
K823180	SA-21 DENTAL UNIT	Nov 22, 1982	Substantially Equivalent	Ritter Co.
K823133	AIR FLOW I	Nov 17, 1982	Substantially Equivalent	Healthco, Inc.
K813106	PORT-OP	Nov 24, 1981	Substantially Equivalent	Portec, Inc.
K801975	LITTLE GIANT I & II HANDPIECE CONTROL	Sep 09, 1980	Substantially Equivalent	Silverman'S
K801685	SPACELINE DENTAL CHAIR-UNIT	Aug 04, 1980	Substantially Equivalent	Pacific Dental Corp.
K801534	LARES AIR PRESSURE GAUGE	Jul 14, 1980	Substantially Equivalent	Lares Manufacturing Co., Inc.
K800395	ARISTOSURG 250	Mar 17, 1980	Substantially Equivalent	Halmon-Locren, Inc.
K790112	MOBILE UNITS, I,II,III,IV	Feb 26, 1979	Substantially Equivalent	Dentsply Intl.
K781882	MODULAT DENTAL SYSTEMS	Dec 28, 1978	Substantially Equivalent	Vacudent Sales Corp.
K781114	ULTRAMATE 990	Aug 14, 1978	Substantially Equivalent	Litton Dental Products
K771890	PERCEPTION SERIES DELIVERY SYS.	Oct 20, 1977	Substantially Equivalent	Chayes Virginia, Inc.
K771252	CB600, TURBINE CONTROL BOL	Jul 15, 1977	Substantially Equivalent	Litton Dental Products
K771251	HU:500, HYGIENASSIST	Jul 15, 1977	Substantially Equivalent	Litton Dental Products