Product Code: EHD FDA class 2 21 CFR 872.1800

Unit, X-Ray, Extraoral With Timer

Dental

The Extraoral X-Ray Unit with Timer is a dental imaging system used to capture panoramic, cephalometric, or other extraoral radiographic views of the jaws, skull, and surrounding structures, with an integrated timer to control exposure duration. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket clearance and compliance with special controls. The product code is EHD, regulated under 21 CFR 872.1800 in the Dental (DE) specialty. This device is eligible for third-party review.

View on FDA

510(k)s

190

FEI Numbers

Registration Numbers

Unique Applicants

120

Years Active

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Basic Information

Product Code: EHD
Device Class: FDA class 2
Regulation Number: 872.1800
Medical Specialty: Dental
Review Panel: RA
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 190 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K260367	Portable Dental X-ray System Model PDX nova	May 27, 2026	Substantially Equivalent	PDX Co., Ltd.
K253864	NOMAD Pro 3	Mar 20, 2026	Substantially Equivalent	Dental Imaging Technologies Corporation
K252110	Dental X-RAY Unit (AJX200)	Mar 12, 2026	Substantially Equivalent	Guangzhou Ajax Medical Equipment Co., Ltd.
K254018	Portable Dental X-ray Device (GT-1)	Feb 19, 2026	Substantially Equivalent	Guilin Refine Medical Instrument Co., Ltd.
K252909	Diagnostic X-Ray Equipment Model POCT22	Feb 03, 2026	Substantially Equivalent	Ningbo Runyes Medical Instrument Co., Ltd.
K251438	Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray )	Sep 04, 2025	Substantially Equivalent	Guilin Woodpecker Medical Instrument Co., Ltd.
K242185	Rextar Pro	Dec 04, 2024	Substantially Equivalent	Raypia Co., Ltd.
K242591	XERO-alpha	Nov 01, 2024	Substantially Equivalent	DRTECH Corporation
K241963	WERAY	Jul 30, 2024	Substantially Equivalent	Picopack Co., Ltd.
K241305	LifeRay Intraoral Handheld X-ray System	Jul 05, 2024	Substantially Equivalent	Lucas Lifecare
K240759	REMEX-GR100	May 13, 2024	Substantially Equivalent	Remedi Co., Ltd.
K233914	XVbeam2000	Feb 08, 2024	Substantially Equivalent	Shenzhen Xpectvision Technology Co., Ltd.
K233395	Portable Dental X-Ray (AXR60 S); Portable Dental X-Ray (AXR65 S)	Jan 03, 2024	Substantially Equivalent	Alliage S/A Industrias Médico Odontológica
K231055	x-mind dc (under trademark Acteon), Owandy-RX DC (under trademark OwandyRadiology)	Dec 28, 2023	Substantially Equivalent	De Götzen S.R.L.
K232085	DVAS (DVAS-M, DVAS-W)	Dec 08, 2023	Substantially Equivalent	Genoray Co., Ltd.
K232012	N1	Nov 28, 2023	Substantially Equivalent	Osstem Implant Co., Ltd.
K232068	HyperLight Portable X-ray Unit	Sep 01, 2023	Substantially Equivalent	Changzhou Sifary Medical Technology Co., Ltd.
K231449	Portable X-ray System Model Ray98(P)	Jul 13, 2023	Substantially Equivalent	Ningbo Runyes Medical Instrument Co., Ltd.
K223780	Lumos 3DX	Jul 06, 2023	Substantially Equivalent	3Dio
K221587	DHX-70H, XTG-70H	Mar 03, 2023	Substantially Equivalent	Digimed Co., Ltd.
K223010	Portable X-ray System	Jan 17, 2023	Substantially Equivalent	Iray Technology Taicang , Ltd.
K222569	Ai Ray Dental X-Ray Device	Nov 23, 2022	Substantially Equivalent	Guilin Woodpecker Medical Instrument Co., Ltd.
K223058	EzRay Air 2 Wall (Model: VEX-S350W)	Oct 26, 2022	Substantially Equivalent	VATECH Co., Ltd.
K220579	Hybrid C70	Sep 01, 2022	Substantially Equivalent	Digimed Co., Ltd.
K222274	FONA XDC	Aug 23, 2022	Substantially Equivalent	Fona S.R.L
K221286	CLAROX	Jun 29, 2022	Substantially Equivalent	Vsi Co., Ltd.
K221233	DT-703	Jun 27, 2022	Substantially Equivalent	Ecotron Co., Ltd.
K220574	HYBRID S70	Apr 22, 2022	Substantially Equivalent	Digimed Co., Ltd.
K213282	ERI Handheld Dental X-ray System (Model AG100)	Apr 04, 2022	Substantially Equivalent	Energy Resources International Co., Ltd. Hsinchu Branch
K211014	Portray	Jul 28, 2021	Substantially Equivalent	Surround Medical Systems
K201800	Portable Dental X-ray (NR-F350, CS 2400P, CS 2300P, R2 Port-X)	Dec 28, 2020	Substantially Equivalent	Nanoray Co., Ltd.
K200182	EzRay Air Portable (Model: VEX-P300)	Feb 11, 2020	Substantially Equivalent	VATECH Co., Ltd.
K192700	Xcam	Dec 27, 2019	Substantially Equivalent	Hdx Will Corp.
K190935	EZER, Portable X-ray System	Dec 19, 2019	Substantially Equivalent	Livermoretech, Inc.
K180671	MINE	Jun 05, 2019	Substantially Equivalent	Rht Co., Ltd.
K190357	Star-X, Intraoral X-ray System	Mar 15, 2019	Substantially Equivalent	Hdx Will Corp.
K182206	RiX70 DC	Sep 13, 2018	Substantially Equivalent	Trident S.R.L
K181891	Portable X-ray System (Model: MiniX-V, Mini X-S)	Aug 10, 2018	Substantially Equivalent	Digimed Co., Ltd.
K180561	MobileX Portable X-ray System	Apr 04, 2018	Substantially Equivalent	Denterprise International, Inc.
K172928	Portable X-ray System	Mar 16, 2018	Substantially Equivalent	Rolence Enterprise, Inc.
K172810	PORT-X IV	Mar 07, 2018	Substantially Equivalent	Genoray Co., Ltd.
K173319	KaVo NOMAD Pro 2 Handheld X-ray System	Nov 16, 2017	Substantially Equivalent	Aribex
K170967	Intraskan DC Plus	Jun 08, 2017	Substantially Equivalent	Skanray Technologies Private Limited
K163705	EzRay Air W	Jan 24, 2017	Substantially Equivalent	VATECH Co., Ltd.
K163519	RX DC	Jan 13, 2017	Substantially Equivalent	Cefla S.C.
K161063	EzRay Air (Model VEX-P300)	Sep 01, 2016	Substantially Equivalent	VATECH Co., Ltd.
K160458	BI IMAGE-X EVOLUTION	Jun 20, 2016	Substantially Equivalent	Radiotecnologia Industrial S.A. DE C.V.
K152859	Portable X-ray System (Model: MINIX-V / MINIX-S)	Dec 03, 2015	Substantially Equivalent	Digimed Co., Ltd. (Digimed Corporation Until 31/12/2012)
K141293	PHOT-X IIS MODEL 505	Sep 03, 2014	Substantially Equivalent	Takara Belmont Corporation
K141497	PORTABLE X-RAY SYSTEM (MODEL:EXARO,XRAY2GO)	Aug 26, 2014	Substantially Equivalent	Osstem Implant Co., Ltd.
K132378	X-MIND UNITY	May 30, 2014	Substantially Equivalent	De Gotzen S.R.L.
K130109	ENDOGRAPH DC	Aug 01, 2013	Substantially Equivalent	Villa Sistemi Medicali S.P.A.
K132041	REXTAR X	Jul 31, 2013	Substantially Equivalent	Meta Biomed, Inc.
K122124	PORTABLE X-RAY SYSTEM	May 16, 2013	Substantially Equivalent	Osstem Implant Co., Ltd.
K122016	REXTAR, REXTAR LCD	Mar 01, 2013	Substantially Equivalent	Meta Biomed, Inc.
K123493	VEX-S 100W INTRAORAL X-RAY SYSTEM	Dec 13, 2012	Substantially Equivalent	VATECH Co., Ltd.
K122582	DENTAL X-RAY Z70 (W); DENTAL X-RAY Z70 (M); DENTAL X-RAY Z70 (C)	Dec 07, 2012	Substantially Equivalent	Denterprise International, Inc.
K111330	AIR TECHNIQUES HIGH FREQUENCY INTRA-ORAL X-RAY	May 27, 2011	Substantially Equivalent	Skanray Technologies
K103600	PORTABLE X-RAY SYSTEM	Apr 08, 2011	Substantially Equivalent	Digimed Corporation
K103579	INTRA SKAN DC	Mar 18, 2011	Substantially Equivalent	Skanray Technologies
K093105	VISTEO	Oct 18, 2010	Substantially Equivalent	Owandy
K091255	MINXRAY, MODEL: BPD60	May 12, 2010	Substantially Equivalent	Minxray, Inc.
K093240	BELRAY II	Mar 22, 2010	Substantially Equivalent	Takara Belmont Corp.
K092772	PORTABLE X-RAY SYSTEM, MODEL HAND-RAY	Jan 06, 2010	Substantially Equivalent	Hanjin Digi-X Co., Ltd.
K092103	DENTAL EXTRAORAL SOURCE X-RAY SYSTEM (ESX)	Oct 09, 2009	Substantially Equivalent	VATECH Co., Ltd.
K091197	PLANMECA PROSENSOR	Jul 29, 2009	Substantially Equivalent	Planmeca Oy
K090749	ROOGRAPH EVO, MODEL 9307XY11Z1, ROTOGRAPH EVO D, MODEL 9307XY1191	May 18, 2009	Substantially Equivalent	Villa Sistemi Medicali S.P.A.
K082875	PORTABLE X-RAY SYSTEM, MODEL DXR -1	Feb 05, 2009	Substantially Equivalent	Exaro Co., Ltd.
K083344	HELIODENT PLUS	Dec 23, 2008	Substantially Equivalent	Sirona Dental Systems GmbH
K082167	PORTABLE X-RAY SYSTEM, MODELS DIOX-602, PROX	Sep 26, 2008	Substantially Equivalent	Digimed Corporation
K081899	ANYRAY PORTABLE X-RAY SYSTEM	Aug 21, 2008	Substantially Equivalent	E-Woo Technology Co., Ltd.
K081664	NOMAD PRO X-RAY SYSTEM	Jun 23, 2008	Substantially Equivalent	Aribex, Inc.
K080076	RX DC X-RAY UNIT	Mar 14, 2008	Substantially Equivalent	Cefla S.C.R.L.
K063121	PORTABLE X-RAY SYSTEM, MODEL PORT-X II	Jan 11, 2007	Substantially Equivalent	Genoray Co., Ltd.
K060640	DIGIREX DIGITAL DENTAL RADIOGRAPHY SYSTEM	Apr 24, 2006	Substantially Equivalent	Dentamerica
K060292	KODAK MODELS 2100 AND 2200	Mar 03, 2006	Substantially Equivalent	Kodak-Trophy
K051795	NOMAD DENTAL X-RAY SYSTEM	Jul 14, 2005	Substantially Equivalent	Aribex, Inc.
K051464	PLANMECA PROMAX WITH DEC (DYNAMIC EXPOSURE CONTROL)	Jun 24, 2005	Substantially Equivalent	Planmeca Oy
K050255	ARTHORALIX 8500, MODELS 110-0199G1, 110-0199G2, 110-0199G3, 110-0199G4	Mar 17, 2005	Substantially Equivalent	Gendex Dental Systems
K043104	KODAK ORTHODONTIC IMAGING AND OMS IMAGING 8.0	Feb 24, 2005	Substantially Equivalent	Practiceworks, Inc.
K043612	ORTHOPANTOMOGRAPH OP200, OP200D, AND ORTHOCEPH OC200, OC200D	Feb 09, 2005	Substantially Equivalent	Instrumentarium Corp. Imaging Division
K050019	IN EXAM INTRAORAL DENTAL X-RAY SYSTEM	Jan 31, 2005	Substantially Equivalent	Kavo America
K043557	MODEL PC-1000 PANORAMIC/CEPHALOMETRIC X-RAY SYSTEMS	Jan 13, 2005	Substantially Equivalent	Panoramic Corp.
K043136	ELITY 70 X-RAY	Jan 06, 2005	Substantially Equivalent	Dental X-Ray E.U.
K043307	CRANEX D	Dec 17, 2004	Substantially Equivalent	Soredex Palodex Group OY
K043092	PREVA, 76IN ARM, 66IN ARM, 56IN ARM, MODELS P7017, P7016, P7015	Dec 13, 2004	Substantially Equivalent	Progeny, Inc.
K042260	PHOT-X II, MODEL 303	Sep 07, 2004	Substantially Equivalent	Takara Belmont USA, Inc.
K040382	CRANEX BASEX D OR CRANEX EXCEL D	Jul 13, 2004	Substantially Equivalent	Soredex Palodex Group OY
K040748	ANA-BEL, MODEL 087D AND ANA-BEL CM, MODEL 187-CM	Jun 02, 2004	Substantially Equivalent	Takara Belmont USA, Inc.
K033755	MINRAY	Apr 29, 2004	Substantially Equivalent	Soredex Palodex Group OY
K040556	TROPHYPAN C WITH ORTHOIMAGING/OMSIMAGING ACCESSORY	Apr 07, 2004	Substantially Equivalent	Eastman Kodak Company
K033690	TROPHYPAN AND TROPHYPAN C	Feb 20, 2004	Substantially Equivalent	Trophy Radiologie
K033073	ORTHOPHOS XG DS/CEPH	Oct 10, 2003	Substantially Equivalent	Sirona Dental Systems GmbH
K032355	ORTHORALIX 9200 DDE, ORTHORALIX 9200 DDE PLUS CEPH, MODELS 5105 0161WW, 5105 0181WW	Sep 25, 2003	Substantially Equivalent	Dentsply Gendex
K031448	RSV (RADIOLOGY SYSTEM VISIODENT	Jul 31, 2003	Substantially Equivalent	Visiodent SA
K031802	CORIX 70 PLUS-USV	Jul 21, 2003	Substantially Equivalent	Coramex, S.A.
K030634	ENDOS DC	Jul 21, 2003	Substantially Equivalent	Villa Sistemi Medicali S.P.A.
K031118	INTRAOS 70	Jul 08, 2003	Substantially Equivalent	Blue X Imaging Srl
K024285	A/T X-RAY 70	Apr 16, 2003	Substantially Equivalent	Air Techniques, Inc.
K030647	EVA DIGITAL DENTAL X-RAY SYSTEM	Mar 20, 2003	Substantially Equivalent	Afp Imaging Corp.
K030185	ENDOS AC/ACP	Mar 11, 2003	Substantially Equivalent	Villa Sistemi Medicali S.P.A.
K022630	MODIFICATION TO FOCUS	Oct 09, 2002	Substantially Equivalent	Instrumentarium Corp.
K021378	PORTABLE HDX INTRAORAL X-RAY	Jun 07, 2002	Substantially Equivalent	Dentalez Group
K021245	DEGOTZEN SYNCHRO	May 03, 2002	Substantially Equivalent	The Gotzen Group, Inc.
K011147	CAVITAT ULTRASOUND BONE DENSITOMETER (CAVITAT)	Feb 15, 2002	Substantially Equivalent	Cavitat Medical Technologies, Inc.
K013955	VERAVIEWEPOCS, MODEL VE	Feb 04, 2002	Substantially Equivalent	J. Morita USA, Inc.
K020070	JB-70 INTRAORAL X-RAY SYSTEM, MODELS 30-A0001/A0002	Feb 01, 2002	Substantially Equivalent	Progeny, Inc.
K013176	MODIFICATION TO: SENS-A-RAY SYSTEM WITH PROIMAGE SOFTWARE	Oct 16, 2001	Substantially Equivalent	Afp Imaging Corp.
K012355	IMAGE-X SYSTEM	Aug 09, 2001	Substantially Equivalent	Tg Group, Inc.
K011619	PROMAX, PANORAMIC X-RAY UNIT WITH CEPHALOSTAT	Jun 29, 2001	Substantially Equivalent	Planmeca Oy
K002062	SAMSUNG 10DR IMPLANT SYSTEM	Nov 09, 2000	Substantially Equivalent	Samsung Sds Co., Ltd.
K002432	STRATO X	Sep 01, 2000	Substantially Equivalent	Villa Sistemi Medicali S.P.A.
K001729	FOCUS	Jul 13, 2000	Substantially Equivalent	Instrumentarium Corp.
K001248	MULTI-PULSE 2000	May 04, 2000	Substantially Equivalent	Imaging Sciences Intl., Inc.
K000771	DIMAX 2	May 03, 2000	Substantially Equivalent	Planmeca Oy
K000672	HELIODENT VARIO	May 02, 2000	Substantially Equivalent	Sirona Dental Systems GmbH
K000428	DIXI 2	Apr 28, 2000	Substantially Equivalent	Planmeca Oy
K000163	PM 2002 PROLINE/AEC	Apr 18, 2000	Substantially Equivalent	Planmeca Oy
K000061	MINXRAY HF70D HIGH FREQUENCY PORTABLE DENTAL X-RAY UNIT	Apr 07, 2000	Substantially Equivalent	Minxray, Inc.
K000551	IMAGE X-70 PLUS DENTAL X-RAY UNIT	Mar 16, 2000	Substantially Equivalent	Medical Device Consultants, Inc.
K994285	ORTHORALIX 9200, ORTHORALIX 9200 PLUS, ORTHORALIX 9200 CEPH, ORTHORALIX 9200 PLUS CEPH	Mar 14, 2000	Substantially Equivalent	Dentsply Intl.
K992610	GENDEX 765DC, MODEL 110-0154	Sep 07, 1999	Substantially Equivalent	Dentsply Intl.
K991455	ORTHOSLICE OS1000 SERIES; PANORAMIC ORTHOSLICE OS 1000: OS1000, OS1000E PANORAMIC AND CEPHALOMETRIC ORTHOSLICE OS1000C,	Jun 25, 1999	Substantially Equivalent	Trophy Radiologie
K991912	MODIFICATION TO DIGIPAN	Jun 22, 1999	Substantially Equivalent	Trophy Radiologie
K991518	PANATOME	Jun 18, 1999	Substantially Equivalent	Imaging Sciences Intl., Inc.
K991310	EXPLOR-X 70	Jun 18, 1999	Substantially Equivalent	Villa Sistemi Medicali S.P.A.
K984030	VIPERSOFT	Feb 10, 1999	Substantially Equivalent	Integra Medical
K984524	AZTECH 70	Jan 14, 1999	Substantially Equivalent	Villa Sistemi Medicali S.P.A.
K980581	PLANMECA DIXI, DIGITAL INTRAORAL X-RAY IMAGING SYSTEM	Apr 17, 1998	Substantially Equivalent	Planmeca Oy
K980543	DENOPTIX BARRIER ENVELOPE (SIZE 0-4)	Apr 14, 1998	Substantially Equivalent	Dentsply Intl.
K974877	CRANEX TOME CEPH, OR CRANEX TOME	Mar 27, 1998	Substantially Equivalent	Orion Corporation Soredex
K974077	VERSAVIEW PANORAMIC-CEPHALOMETRIC DENTAL X-RAY SYS.	Jan 20, 1998	Substantially Equivalent	J. Morita USA, Inc.
K972921	SANKO INTRAORAL DENTAL X-RAY	Jan 06, 1998	Substantially Equivalent	Sanko X-Ray Manufacturing Co., Ltd.
K973642	ORTHOPANTOMOGRAPH OP100 AND ORTHOCEPH OC100	Nov 21, 1997	Substantially Equivalent	Instrumentarium Imaging, Inc.
K973476	KODAK DIGITAL SCIENCE-DENTAL IMAGE VIEWER	Nov 10, 1997	Substantially Equivalent	Eastman Kodak Company
K972968	ROTOGRAPH PLUS	Oct 08, 1997	Substantially Equivalent	Chicago X-Ray Systems, Inc.
K972312	SIEMENS ORTHOPHOS DS/DS CEPH	Sep 15, 1997	Substantially Equivalent	Siemens AG
K972249	ORTHOPHOS PLUS AND ORTHOPHOS PLUS/CD	Sep 12, 1997	Substantially Equivalent	Pelton & Crane Co.
K962422	INFIMED DENTAL SYSTEM	Sep 11, 1997	Substantially Equivalent	Infimed, Inc.
K972168	SIDEXIS DIGITAL RADIOGRAPHY SYSTEM	Sep 05, 1997	Substantially Equivalent	Pelton & Crane Co.
K970812	PM 2002 CC PROLINE	Aug 05, 1997	Substantially Equivalent	Planmeca Oy
K970850	SCANRITE DFS	May 14, 1997	Substantially Equivalent	Scanrite Systems
K970975	PROSTYLE INTRA	Apr 01, 1997	Substantially Equivalent	Planmeca Oy
K965203	RADX SYSTEM	Mar 17, 1997	Substantially Equivalent	Electro Medical Systems, Inc.
K970263	PM 2002 CC PROLINE	Feb 26, 1997	Substantially Equivalent	Planmeca Oy
K965072	PANOURA ULTRA PAN AND PANOURA ULTRA PAN/CEPH PANORAMIC/CEPHALOMETRIC X-RAY UNIT	Jan 27, 1997	Substantially Equivalent	Kaycor Intl., Ltd.
K963403	ACURAY DIGITAL X-RAY	Jan 02, 1997	Substantially Equivalent	New Image Industries, Inc.
K964659	ORTHORALIX E/GX-9000 PANORAMIC X-RAY SYSTEM	Dec 23, 1996	Substantially Equivalent	Dentsply Intl.
K963699	BELRAY/MODEL 096, DENTAL INTRAORAL X-RAY	Dec 23, 1996	Substantially Equivalent	Belmont Equipment Corp.
K962631	DEXIS MODEL 601 DENTAL ELECTRONIC IMAGING SYSTEM	Nov 26, 1996	Substantially Equivalent	Fair Image, Inc.
K963185	ELECTRONIC X-RAY TIMER 1400A, 1400AW AND UNIVERSAL DIGITAL DENTAL X-RAY TIMER	Oct 02, 1996	Substantially Equivalent	Electronic Control Concepts
K961826	DIGIPAN	Sep 23, 1996	Substantially Equivalent	Trophy Radiologie
K962337	ELITYS OR ELITYS-E	Jul 25, 1996	Substantially Equivalent	Trophy Radiologie
K962120	TOMOGRAPH ACCESSORIES	Jul 25, 1996	Substantially Equivalent	Steri-Oss, Inc.
K955429	PROSTYLE INTRA	Dec 11, 1995	Substantially Equivalent	Planmeca Oy
K952763	PANORAMIC X-RAY UNIT (MODIFICATION)	Oct 07, 1995	Substantially Equivalent	Planmeca Oy
K931300	FLASH DENT	Mar 21, 1994	Substantially Equivalent	Chicago X-Ray Systems, Inc.
K935046	GX-770 X-RAY CONTROL, MODEL 46-404600G4	Feb 18, 1994	Substantially Equivalent	Gendex Corp.
K932111	DENTAL X-RAY UNIT	Jan 25, 1994	Substantially Equivalent	Castellini S.P.A.
K934063	PANORAMIC X-RAY UNITS, MODIFICATION	Dec 15, 1993	Substantially Equivalent	Planmeca Oy
K925094	VISUALIX RADIOGRAPHIC IMAGE DETECTING AND PROCESS	Sep 29, 1993	Substantially Equivalent	Gendex Corp.
K931001	ORALIX DC	Sep 14, 1993	Substantially Equivalent	Gendex Corp.
K931725	ALPHA II	Jul 14, 1993	Substantially Equivalent	Dynarad Corp.
K930338	ORTHOCEPH OC100	Apr 27, 1993	Substantially Equivalent	Instrumentarium Corp.
K926575	MAMMOTEST PRODUCT, MODIFICATION	Mar 30, 1993	Substantially Equivalent	Fischer Imaging Corp.
K923360	PORT-XD	Mar 30, 1993	Substantially Equivalent	Mobile Dental Equipment Corp.
K924130	COFFMAN IMPLANT TOMOGRAPH	Nov 27, 1992	Substantially Equivalent	Coffman Dental
K923067	SENS-A-RAY	Nov 27, 1992	Substantially Equivalent	Regam Medical Systems
K912893	ORTHOPANTOMOGRAPH 100	Nov 05, 1991	Substantially Equivalent	Instrumentarium Corp.
K913652	COFFMAN TOMOGRAPH	Oct 30, 1991	Substantially Equivalent	Coffman Dental
K894935	S-70 PORTABLE DENTAL X-RAY SYSTEM	Apr 25, 1990	Substantially Equivalent	Lorad Medical Systems, Inc.
K895467	ORTHOPHOS AND ORTHOPHOS C	Nov 17, 1989	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K882436	LASER - 1000	Aug 04, 1988	Substantially Equivalent	Panoramic Corp.
K875212	PXS MODEL PXS7-730EA DENTAL X-RAY SOURCE	Jun 17, 1988	Substantially Equivalent	Kevex Corp.
K872825	AXIAL TOME, 60, FLUORO AND TOMAX	Mar 31, 1988	Substantially Equivalent	Axialtome Corp.
K874238	MODEL 2001 CP, PHOTON I, DENTAL, INTRAORAL X-RAY	Dec 07, 1987	Substantially Equivalent	Belmont Equipment Corp.
K872240	PORTABLE DENTAL X-RAY UNIT MODEL 4000	Jul 16, 1987	Substantially Equivalent	Home/Office Dental, Inc.
K871051	FIAD EXPLOR-X; MODEL 70 KVP	May 04, 1987	Substantially Equivalent	United States Dental
K870236	PANORAMIC X-RAY MODEL PC-1000	Feb 13, 1987	Substantially Equivalent	Panoramic Corp.
K864474	DENTAL RADIOGRAPHIC 90, MODEL PM 2002 CC PANORAMIC	Nov 26, 1986	Substantially Equivalent	Planmeca USA, Inc.
K860835	CEPHALOSTAT	Jul 01, 1986	Substantially Equivalent	Dallas Dental Co.
K854741	X-RANGE 65	Mar 06, 1986	Substantially Equivalent	Alpine Dental Equipment Co.
K851095	INTRAORAL DENTAL X-RAY SYSTEM 70-X	Sep 03, 1985	Substantially Equivalent	Trophy Radiologie
K811103	GE 900	Jun 09, 1981	Substantially Equivalent	General Electric Co.
K800133	PANOREX II DENTAL X-RAY UNIT	Mar 03, 1980	Substantially Equivalent	Pennwalt Corp.
K792581	GENERAL ELECTRIC PANELIPSE LD	Jan 16, 1980	Substantially Equivalent	General Electric Co.
K781288	DENTAL X-RAY UNIT HELIODENT 70	Sep 11, 1978	Substantially Equivalent	Siemens Corp.
K781286	DENTAL X-RAY UNIT	Sep 11, 1978	Substantially Equivalent	Siemens Corp.
K780469	PANORAMIC X-RAY, DENTAL	Apr 10, 1978	Substantially Equivalent	Den-Tal-Ez Mfg Co., Inc.
K772164	PANORAMIC X-RAY SYSTEM MODEL A	Dec 02, 1977	Substantially Equivalent	Sybron Corp.