Product Code: MUH FDA class 2 21 CFR 872.1800

System, X-Ray, Extraoral Source, Digital

Dental

A Digital Extraoral Source X-Ray System is a dental radiographic imaging system that captures digital X-ray images of the teeth, jaws, and surrounding structures from outside the mouth, including panoramic and cephalometric systems, used for dental diagnosis and treatment planning. It is FDA Class 2, requiring 510(k) clearance, with product code MUH under 21 CFR 872.1800 in the Dental specialty. The device is not an implant and is not life-sustaining.

View on FDA

510(k)s

206

FEI Numbers

Registration Numbers

Unique Applicants

118

Years Active

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Basic Information

Product Code: MUH
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 206 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K251793	SOTA Cloud Smart Sensor (1.5)	Mar 03, 2026	Substantially Equivalent	Sota Cloud Corp.
K252570	EzSensor HD, EzSensor UHD	Nov 10, 2025	Substantially Equivalent	Qpix Solutions, Inc.
K250687	Cocoon Solo (DX-7020s)	Oct 24, 2025	Substantially Equivalent	Dexcowin Global, Inc.
K251206	Digital X-Ray DentiMax Pro Imaging System	Sep 24, 2025	Substantially Equivalent	Dentimax, Inc.
K240040	VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan Ceph 2.0 (ProVecta S-Pan Ceph); ProVecta S-Pan 2.0 (ProVecta S-Pan)	Oct 25, 2024	Substantially Equivalent	VATECH Co., Ltd.
K242778	X Sensor (Model: IOS-A15IF, HDI-15DGF)	Oct 11, 2024	Substantially Equivalent	Qpix Solutions, Inc.
K241649	DUO1 and DUO2	Jul 05, 2024	Substantially Equivalent	Zinnovi, Inc.
K232325	RAYSCAN a-Expert	Apr 18, 2024	Substantially Equivalent	Ray Co., Ltd.
K231660	Digital image scanner of dental	Dec 20, 2023	Substantially Equivalent	Jiangsu Dynamic Medical Technology Co., Ltd.
K233053	DEXIS Ti2 Intraoral Sensor, DEXIS IXS Size 1 Intraoral Sensor, DEXIS IXS Size 2 Intraoral Sensor	Nov 21, 2023	Substantially Equivalent	Dental Imaging Technologies Corporation
K232552	TuxDeluxe (Size 1 6100B, Size 2 6101B)	Oct 20, 2023	Substantially Equivalent	Tuxedo Imaging, LLC
K230998	Digital Wireless Intraoral X-Ray Sensor	Oct 20, 2023	Substantially Equivalent	Iray Imaging Technology (Haining) Limited
K230916	WeSensor	Oct 10, 2023	Substantially Equivalent	Picopack, Inc.
K232255	EZSensor XHD	Sep 27, 2023	Substantially Equivalent	Qpix Solutions, Inc.
K232158	GenX-CR	Sep 13, 2023	Substantially Equivalent	Genoray Co., Ltd.
K231202	QuickRayPRO	Jun 22, 2023	Substantially Equivalent	Denterprise International, Inc.
K230811	Digital Intraoral X-Ray Sensor	Apr 21, 2023	Substantially Equivalent	Iray Imaging Technology (Haining) Limited
K230732	Eagle S/Saevo Slim/D700 Slim	Apr 11, 2023	Substantially Equivalent	Alliage S/A Industrias Medica Odontológico.
K230095	ScanX Swift 2.0, ScanX Swift View 2.0	Feb 06, 2023	Substantially Equivalent	Durr Dental SE
K221955	Brasseler GEM, Brasseler GEM10, Brasseler GEM15, Brasseler GEM20	Aug 31, 2022	Substantially Equivalent	Realcloud Imaging Inc. Dba Realcloud Imaging
K221008	HDR Sensor- HDR361 (Size 1), HDR Sensor- HDR461 (Size 2)	Jun 22, 2022	Substantially Equivalent	Shanghai Handy Medical Equipment Co., Ltd.
K220423	PAPAYA & PAPAYA Plus	May 19, 2022	Substantially Equivalent	Genoray Co., Ltd.
K220556	OpenSensorX Series	Apr 13, 2022	Substantially Equivalent	Dentimax, Inc.
K220422	Dental sensors NanoPix1, NanoPix2	Mar 11, 2022	Substantially Equivalent	Iray Technology Taicang , Ltd.
K214091	Dental Image Plate Scanner, Model DFC-4T-SMART	Mar 02, 2022	Substantially Equivalent	Hefei Dentafilm Medical Equipment Co., Ltd.
K220277	Digital Intraoral X-ray Sensor	Feb 17, 2022	Substantially Equivalent	Shenzhen Xpectvision Technology Co., Ltd.
K213637	JAZZ Solo sensor	Dec 10, 2021	Substantially Equivalent	Jazz Imaging, LLC Dba Jazz Imaging
K212279	Digital Intraoral X-ray Imaging System	Oct 07, 2021	Substantially Equivalent	Iray Technology Taicang , Ltd.
K212080	Imaging Plate Scanner, i-Scan	Sep 27, 2021	Substantially Equivalent	Guilin Woodpecker Medical Instrument Co., Ltd.
K202369	RXS 1000	Sep 15, 2021	Substantially Equivalent	Rolence Enterprise, Inc.
K212103	StarX-1, StarX-2, StarX PRO-1 and StarX PRO-2	Aug 30, 2021	Substantially Equivalent	Fona S.R.L
K211317	CRUXVIEW	Jul 29, 2021	Substantially Equivalent	Cruxell Corp.
K211688	DC-Air and Athlos-1 and Athlos-Air	Jul 22, 2021	Substantially Equivalent	Athlos OY
K210312	PlutoX Digital Intraoral X-Ray Imaging System	Apr 23, 2021	Substantially Equivalent	Iray Technology Taicang , Ltd.
K203116	SensorX	Mar 19, 2021	Substantially Equivalent	Durr Dental SE
K203374	X-MIND prime (under trade mark Acteon), I-MAX (under trade mark Owandy Radiology)	Feb 05, 2021	Substantially Equivalent	De Götzen S.R.L.
K202664	Clio Prime and Clio Pedo	Nov 06, 2020	Substantially Equivalent	Sota Precision Optics, Inc. Dba Sota Imaging
K202633	ScanX Edge	Oct 07, 2020	Substantially Equivalent	Dürr Dental SE
K200625	I-View Gold and Imagen Gold Dental Sensors	Apr 15, 2020	Substantially Equivalent	Trident S.R.L
K200284	R-Sensor, R-Sensor	Feb 28, 2020	Substantially Equivalent	Remedi Co., Ltd.
K191719	X-MIND Trium	Feb 20, 2020	Substantially Equivalent	De Gotzen S.R.L.
K192766	Digital Intraoral Imaging Plate System	Dec 05, 2019	Substantially Equivalent	Fsusen Technology Co., Ltd.
K191623	ScanX Touch/ScanX Duo Touch	Aug 21, 2019	Substantially Equivalent	Air Techniques, Inc.
K190234	ODI HD Dental Sensor	Mar 01, 2019	Substantially Equivalent	Cnd Global Technologies, Inc.
K183637	Cruxcan (CRX-1000)	Feb 12, 2019	Substantially Equivalent	Cruxell Corp.
K182198	Panoura X-ERA PF/NF/MF	Jan 31, 2019	Substantially Equivalent	The Yoshida Dental Mfg. Co., Ltd.
K181297	DENTIOIII series (DENTIOIII, DENTIOIII-S)	Nov 21, 2018	Substantially Equivalent	Hdx Will Corp.
K181636	Aurora	Jul 20, 2018	Substantially Equivalent	Sodium Systems, LLC
K181358	Televere Digital Dental Imaging System	Jun 20, 2018	Substantially Equivalent	Televere Systems, Inc.
K173646	FS Ergo	Dec 19, 2017	Substantially Equivalent	Palodex Group OY
K172918	DEXIS Titanium, KaVo IXS HD (Size 1, Size 2)	Dec 18, 2017	Substantially Equivalent	Kavo Dental Technologies, LLC
K173046	Cocoon Portable Handheld X-Ray System	Oct 26, 2017	Substantially Equivalent	Dexcowin Co., Ltd.
K162190	Rotograph Prime (under trade mark Villa Sistemi Medicali), I-MAX (under trade mark Owandy Radiology)	Jul 06, 2017	Substantially Equivalent	Villa Sistemi Medicali S.P.A.
K170733	ScanX Intraoral View	May 01, 2017	Substantially Equivalent	Duerr Dental AG
K170731	System, X-Ray, Extra oral Source, Digital, PaX-i Plus, PaX-i Insight	Apr 04, 2017	Substantially Equivalent	VATECH Co., Ltd.
K163175	Bel-Cypher Pro	Mar 20, 2017	Substantially Equivalent	Takara Belmont Corporation
K163224	JAZZ SOLO Sensor	Mar 09, 2017	Substantially Equivalent	Jazz Imaging, LLC
K163282	Apex Dental Sensors	Feb 28, 2017	Substantially Equivalent	Masterlink, LLC
K162619	I View and Imagen Sensor	Nov 04, 2016	Substantially Equivalent	Trident S.R.L
K162585	SuniIQ Digital Radiography System	Nov 04, 2016	Substantially Equivalent	Suni Medical Imaging, Inc.
K161131	FONA Pan/Ceph	Nov 03, 2016	Substantially Equivalent	Fona S.R.L
K160788	RIOScan (RPS500)	Apr 15, 2016	Substantially Equivalent	Ray Co., Ltd.
K160386	ReadeR, VieweR, QuickScan PSP	Mar 10, 2016	Substantially Equivalent	Trident S.R.L
K153144	TIO-H DIGITAL RADIOGRAPHY SENSOR	Feb 10, 2016	Substantially Equivalent	Denttio, Inc.
K152162	Myray- HYPERION X5	Dec 24, 2015	Substantially Equivalent	Cefla S.C.
K151926	QuickRay HD Intraoral Sensor	Dec 14, 2015	Substantially Equivalent	Denterprise International, Inc.
K153060	Digital Dental Intra Oral Sensor, EzSensor Classic, EzSensor HD, HDI-P, HDI-S	Nov 10, 2015	Substantially Equivalent	Rayence Co., Ltd.
K150823	EDLENi Intra-Oral Sensor	Aug 26, 2015	Substantially Equivalent	Edlen Imaging, LLC
K151087	CS 8100SC, CS8100SC Access	Aug 21, 2015	Substantially Equivalent	Trophy
K142995	SOPIX	Aug 17, 2015	Substantially Equivalent	Sopro - Acteon Group
K151053	PSPIX 2 scanner, Imaging Plate Size 0 for PSPIX2 scanner, Imaging Plate Size 1 for PSPIX2 scanner, Imaging Plate Size 2 for PSPIX2 scanner, Imaging Plate Size 3 for PSPIX2 scanner	Jul 31, 2015	Substantially Equivalent	Sopro - Acteon Group
K151707	EzSensor Soft, EzSensor Soft i, EzSensor Bio, and EzSensor Bio i	Jul 19, 2015	Substantially Equivalent	Rayence Co., Ltd.
K150797	Digital Dental Intra Oral Sensor, EzSensor Smart	May 01, 2015	Substantially Equivalent	Rayence Co., Ltd.
K142058	RAYSCAN A-EXPERT	Apr 22, 2015	Substantially Equivalent	Ray Co., Ltd.
K143703	NICAL SMART MICRO CR system for intraoral dental images	Mar 18, 2015	Substantially Equivalent	Nical Spa
K143753	Digital Dental Intra Oral Sensor, EzSensor Soft, EzSensor Bio	Mar 10, 2015	Substantially Equivalent	Rayence Co., Ltd.
K141700	PAPAYA PLUS, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM	Oct 31, 2014	Substantially Equivalent	Genoray Co., Ltd.
K140013	SOPIX INSIDE, SOPIX2 INSIDE	Sep 05, 2014	Substantially Equivalent	Sopro - Acteon Group
K141130	ENCOMPASS	Jul 30, 2014	Substantially Equivalent	Panoramic Corp.
K133206	Z-RAY INTRA-ORAL DIGITAL RADIOGRAPHY SYSTEM	May 13, 2014	Substantially Equivalent	Zuma Dental, LLC
K134055	ADX4000W	May 09, 2014	Substantially Equivalent	Dexcowin Co., Ltd.
K133271	OPTEO, VIDEOGRAPH HD	Apr 28, 2014	Substantially Equivalent	Owandy
K133007	DX3000-L	Apr 24, 2014	Substantially Equivalent	Dexcowin Co., Ltd.
K133231	DIGORA OPTIME	Mar 20, 2014	Substantially Equivalent	Instrumentarium Dental, Palodex Group OY
K130419	PAPAYA PLUS, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM	Nov 06, 2013	Substantially Equivalent	Genoray Co., Ltd.
K131693	RAYSCAN A-EXPERT	Nov 01, 2013	Substantially Equivalent	Ray Co., Ltd.
K131442	FIRECR DENTALIMAGING SYSTEM	Sep 06, 2013	Substantially Equivalent	3Disc Americas
K130088	PORT VIEW, DIGITAL X-RAY SENSOR SYSTEM	Jul 18, 2013	Substantially Equivalent	Genoray Co., Ltd.
K130585	PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM, PAX-I DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM	Jul 15, 2013	Substantially Equivalent	VATECH Co., Ltd.
K122918	RAYSCAN A-EXPERT	Mar 15, 2013	Substantially Equivalent	Ray Co., Ltd.
K122806	IMAGE WORKS PANOURA	Mar 08, 2013	Substantially Equivalent	Mic International
K121800	POINT 500 HD POINT500C HD	Jan 24, 2013	Substantially Equivalent	Pointnix Co., Ltd.
K122643	VANTAGE MODEL V5000, V5100, V5000C, V5100C	Jan 07, 2013	Substantially Equivalent	Midmark Corp.
K123419	EVA SELECT DIGITAL DENTAL IMAGING SYSTEM	Dec 27, 2012	Substantially Equivalent	Afp Imaging Corp.
K122155	PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM PAX-I DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM	Sep 04, 2012	Substantially Equivalent	VATECH Co., Ltd.
K120263	VOLUX 21C, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM	Jul 10, 2012	Substantially Equivalent	Genoray Co., Ltd.
K120975	CS 8100 CS 8100 ACCESS	Jun 22, 2012	Substantially Equivalent	Trophy
K120106	APIXIA DIGIREX DIGITAL DENTAL REDIOGRAPHY SYSTEM	May 07, 2012	Substantially Equivalent	Apixia, Inc.
K113672	PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM	Mar 27, 2012	Substantially Equivalent	VATECH Co., Ltd.
K120318	VIVI ERGON-X HF	Mar 06, 2012	Substantially Equivalent	Vivi S.R.L.
K113497	HYPERION	Jan 17, 2012	Substantially Equivalent	Cefla S.C. Cefla Dental Group
K111103	DIGITAL X-RAY IMAGING SYSTEM	Jan 05, 2012	Substantially Equivalent	Rf Co., Ltd.
K102456	INTRAORAL BELSENSOR GOLD	Dec 15, 2011	Substantially Equivalent	Takara Belmont USA, Inc.
K112380	CLEARVISION	Nov 22, 2011	Substantially Equivalent	Midmark Corp.
K111649	CS 7600	Sep 23, 2011	Substantially Equivalent	Carestream Health, Inc.
K103290	EDLEN IMAGING - GEMINI DUSB	Sep 19, 2011	Substantially Equivalent	Edlen Imaging, LLC
K111152	ROTOGRAPH EVO 3D	Jul 22, 2011	Substantially Equivalent	Villa Sistemi Medicali S.P.A.
K111231	PANOURA 18S	Jul 13, 2011	Substantially Equivalent	The Yoshida Dental Mfg. Co., Ltd.
K110768	COMPUTED DENTAL RADIOGRAPHY	Apr 20, 2011	Substantially Equivalent	Schick Technologies, Inc.
K110371	ENCOMPASS HF100- EAGLE PANORAMIC/CEPHALOMETRIC X-RAY	Mar 17, 2011	Substantially Equivalent	Panoramic Corp.
K103689	PLANMECA PROMAX 3D MID	Mar 17, 2011	Substantially Equivalent	Planmeca Oy
K110160	BEL-CYPHER N	Feb 17, 2011	Substantially Equivalent	Takara Belmont Corporation
K102124	DENTAL COMPUTED TOMOGRAPHY X-RAY SYSTEM	Oct 22, 2010	Substantially Equivalent	VATECH Co., Ltd.
K100960	WDS X-POD AND ZEN-X DIGITAL X-RAY SENSORS	Oct 21, 2010	Substantially Equivalent	Cefla Dental Group
K093683	ORTHOPANTOMOGRAPH OP300	Oct 06, 2010	Substantially Equivalent	Instrumentarium Dental, Palodex Group OY
K101661	MYRAY HYPERION	Sep 16, 2010	Substantially Equivalent	Cefla Dental Group
K092329	SOPIX 2	Jul 20, 2010	Substantially Equivalent	Sopro
K093590	PLANMECA PROMAX 3D MAX	May 12, 2010	Substantially Equivalent	Planmeca Oy
K093478	KODAK RVG 6500 SYSTEM AND KODAK RVG 6500 IPS SYSTEM	Apr 26, 2010	Substantially Equivalent	Trophy
K092171	VOLUX, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM	Apr 26, 2010	Substantially Equivalent	Genoray Co., Ltd.
K100317	DIGITAL X-RAY IMAGING SYSTEM (PAX-PRIMO) MODEL PAX-PRIMO	Mar 24, 2010	Substantially Equivalent	VATECH Co., Ltd.
K090526	MEDICAL IMAGE PROCESSING UNIT, MODEL EZSENSOR	Dec 02, 2009	Substantially Equivalent	E-Woo Technology
K092591	ORTHOPANTOMOGRAPH OP30	Nov 20, 2009	Substantially Equivalent	Instrumentarium Dental, Palodex Group OY
K092547	DENTIMAX DIGITAL X-RAY IMAGING SYSTEM SENSOR SIZE 1, 2, DENTIMAX USB CONTROL BOX	Oct 30, 2009	Substantially Equivalent	Dentimax
K092537	DIGITAL X-RAY SENSOR, MODEL E9539,E9505,E9502, E9540	Aug 27, 2009	Substantially Equivalent	Toshiba America Electronic Components, Inc.
K091866	PROGENY VANTAGE PANORAMIC X-RAY SYSTEM	Jul 20, 2009	Substantially Equivalent	Midmark
K083057	I-MAX TOUCH	Jun 02, 2009	Substantially Equivalent	Owandy
K090458	DEXIS SENSOR	May 28, 2009	Substantially Equivalent	Dexis, LLC
K090020	BEL-CYPHER, MODEL Y977	Mar 13, 2009	Substantially Equivalent	Takara-Belmont Co., Ltd.
K083532	ADX4000-L, DX3000-L	Mar 10, 2009	Substantially Equivalent	Dexcowin Co., Ltd.
K082972	KODAK 9500	Dec 05, 2008	Substantially Equivalent	Trophy
K081088	MYRAY SKYVIEW	Nov 06, 2008	Substantially Equivalent	Cefla S.C.
K081925	SNAPSHOT	Sep 02, 2008	Substantially Equivalent	Instrumentarium Dental, Palodex Group OY
K081903	XIOS PLUS WALL-MODULE	Aug 26, 2008	Substantially Equivalent	Sirona Dental Systems GmbH
K080889	KODAK 9000C EXTRAORAL IMAGING SYSTEM	Apr 29, 2008	Substantially Equivalent	Trophy
K073696	VERAVIEWEPOCS	Apr 08, 2008	Substantially Equivalent	J. Morita USA, Inc.
K073365	DENTAL DIGITAL X-RAY IMAGING SYSTEM	Apr 08, 2008	Substantially Equivalent	VATECH Co., Ltd.
K073435	KODAK 9000, KODAK 9000 3D	Feb 11, 2008	Substantially Equivalent	Trophy
K073350	SCANORA 3D	Dec 19, 2007	Substantially Equivalent	Soredex Palodex Group OY
K072134	SCHICK COMPUTED ORAL RADIOLOGY SYSTEM	Nov 02, 2007	Substantially Equivalent	Schick Technologies, Inc.
K072244	PLANMECA PROONE	Sep 21, 2007	Substantially Equivalent	Planmeca Oy
K072357	NEWTOM VG COMPUTED TOMOGRAPHY X-RAY SYSTEM	Sep 18, 2007	Substantially Equivalent	Afp Imaging Corp.
K070811	CORDLESS PORTABLE DENTAL X-RAY SYSTEM, MODEL ADX4000	Jul 05, 2007	Substantially Equivalent	Dexco
K063837	SIGMA M	Jul 02, 2007	Substantially Equivalent	Instrumentarium Dental, Palodex Group OY
K070664	PROGENY IMAGING SOFTWARE, MODEL# 500-405 (6,7,8).	Apr 26, 2007	Substantially Equivalent	Progeny, Inc.
K070535	RETROPAN CCD-TWAIN-USB	Apr 24, 2007	Substantially Equivalent	Video Dental Concepts, Inc.
K070505	KRYSTAL-X WIFI	Apr 05, 2007	Substantially Equivalent	Owandy
K070304	DIGORA PCT/DIGIPOD	Mar 27, 2007	Substantially Equivalent	Soredex Palodex Group OY
K070219	SUNIRAY II DIGITAL RADIOGRAPHY SYSTEM	Feb 07, 2007	Substantially Equivalent	Suni Medical Imaging, Inc.
K063459	CRANEX NOVUS	Dec 26, 2006	Substantially Equivalent	Soredex Palodex Group OY
K062403	IMAX CEPH DIGITAL X-RAY SENSOR	Nov 14, 2006	Substantially Equivalent	Owandy
K062529	BELMAX CM MODEL X168	Oct 05, 2006	Substantially Equivalent	Takara Belmont USA, Inc.
K061284	I-CAT SCANNER	Jul 03, 2006	Substantially Equivalent	Imaging Sciences Intl., Inc.
K053172	UNIVERSAL-X (USA) OR /KRYSTAL-X (EUROPE)	Jun 09, 2006	Substantially Equivalent	Owandy Sas
K061114	WDS, SIZE 2 AND SIZE 2	Jun 06, 2006	Substantially Equivalent	Cefla S.C.R.L.
K060892	GALILEOS	Apr 14, 2006	Substantially Equivalent	Sirona Dental Systems GmbH
K060328	PLANMECA PROMAX 3D	Mar 15, 2006	Substantially Equivalent	Planmeca Oy
K060178	VIX WIN PRO	Mar 10, 2006	Substantially Equivalent	Gendex Dental Systems
K053558	CEPH, MODEL 4900	Feb 17, 2006	Substantially Equivalent	Schick Technologies, Inc.
K060179	BIO-RAY SDX DIGITAL X-RAY SYSTEM	Feb 08, 2006	Substantially Equivalent	Sigma Biomedics, Inc.
K060079	KODAK MODEL CR-7400 DIGITAL RADIOGRAPHY SYSTEM	Feb 08, 2006	Substantially Equivalent	Eastman Kodak Company
K060149	SUNIPAN IMAGING SYSTEM & ACCESSORIES	Feb 03, 2006	Substantially Equivalent	Suni Medical Imaging, Inc.
K053221	CDMX-H	Jan 12, 2006	Substantially Equivalent	Camsight Co., Inc.
K053220	VERAVIEW IC 5, MODEL XDP1	Jan 06, 2006	Substantially Equivalent	J. Morita USA, Inc.
K051664	SCAN300FP / RETROPAN (VDC)	Jul 20, 2005	Substantially Equivalent	Oy Ajat, Ltd.
K050693	ACCENT	May 26, 2005	Substantially Equivalent	Air Techniques, Inc.
K041834	ADR PLUS SSXI IMAGING DEVICE FOR X-RAY SYSTEMS SUCH AS X-CALIBER, X-CALIBER CM, ANA-BEL AND ANA-BEL CM	Dec 03, 2004	Substantially Equivalent	Takara Belmont USA, Inc.
K042736	CDX DIGITAL X-RAY IMAGING SYSTEM	Oct 13, 2004	Substantially Equivalent	Cnc Imaging, Inc.
K042372	HDS INTRA-ORAL IMAGING SYSTEM	Oct 04, 2004	Substantially Equivalent	Vatech Value Added Technology Co., Ltd.
K041120	EV APAN DIGITAL, MODEL K1VSM2000	Aug 30, 2004	Substantially Equivalent	Afp Imaging Corp.
K041831	PROGENY MPSE INTRAORAL DENTAL X-RAY SENSOR	Aug 09, 2004	Substantially Equivalent	Progeny, Inc.
K041580	IMAGERAYI	Jun 29, 2004	Substantially Equivalent	Henry Schein, Inc.
K041050	DIGORA OPTIME (OR DIGORA ONTIME)	Jun 15, 2004	Substantially Equivalent	Soredex Palodex Group OY
K024186	X-VIEW	Apr 01, 2004	Substantially Equivalent	Sometech Corporation
K033147	CLEARTOOTH DIGITAL X-RAY SYSTEM	Dec 30, 2003	Substantially Equivalent	Cleartooth Electronics, Inc.
K033248	HITACHI CB MERCURAY DENTAL CONE-BEAM X-RAY SYSTEM	Oct 20, 2003	Substantially Equivalent	Hitachi Medical Systems America, Inc.
K031801	PANTOS, MODELS: PANTOS 16, AND PANTOS DG	Sep 11, 2003	Substantially Equivalent	Blue X Imaging Srl
K031291	CDR PANX, MODEL 4792	May 05, 2003	Substantially Equivalent	Schick Technologies, Inc.
K023346	TROPHYPAN	Jan 03, 2003	Substantially Equivalent	Trophy Radiologie
K023292	APEX HRI DIGITAL RADIOGRAPHY SYSTEM	Dec 13, 2002	Substantially Equivalent	Krugman Technologies, Inc.
K022953	MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM	Oct 02, 2002	Substantially Equivalent	Schick Technologies, Inc.
K021718	INTRAORAL IMAGING SYSTEM, MODEL SUNI-RAY	Aug 15, 2002	Substantially Equivalent	Suni Imaging Microsystems, Inc.
K021542	ADC DENTAL	Aug 06, 2002	Substantially Equivalent	Agfa Corp.
K020588	X-IMAGE DIGITAL X-RAY SYSTEM	Jun 13, 2002	Substantially Equivalent	Escape Technology, Inc.
K013893	SCANX	Feb 01, 2002	Substantially Equivalent	Air Techniques, Inc.
K012514	DIGIPAN / DPI	Dec 21, 2001	Substantially Equivalent	Trophy Radiologie
K013271	DXS DIGITAL X-RAY SYSTEM	Dec 13, 2001	Substantially Equivalent	Douglas C. Yoon, Dds
K013659	MODIFICATION TO SIDEXIS DIGITAL RADIOGRAPHY IMAGING SYSTEM	Dec 06, 2001	Substantially Equivalent	Sirona Dental Systems GmbH
K013650	ORTHOPHOS DS/DC CEPH, ORTHOPHOS 5/PLUS/CD	Dec 06, 2001	Substantially Equivalent	Sirona Dental Systems GmbH
K012170	DIGORA PCT	Aug 10, 2001	Substantially Equivalent	Soredex Palodex Group OY
K010915	CDMX	May 21, 2001	Substantially Equivalent	Camsight Co., Inc.
K002425	MEDIADENT HDX/MMD HDX SP XRAY SENSOR	Dec 21, 2000	Substantially Equivalent	Multi Media Dental Systems, Inc.
K001928	SIGMA	Aug 02, 2000	Substantially Equivalent	Instrumentarium Imaging, Inc.
K001439	ORTHOCEPH OC100 D	Jun 22, 2000	Substantially Equivalent	Instrumentarium Corp.
K992392	RTLX	Mar 31, 2000	Substantially Equivalent	Infimed, Inc.
K000454	DIMEX 2	Mar 31, 2000	Substantially Equivalent	Planmeca Oy
K993958	IDX-60 INTRAORAL X-RAY	Feb 14, 2000	Substantially Equivalent	X-Cel X-Ray Corp.
K992385	ORTHOPANTOMOGRAPH OP100D	Sep 28, 1999	Substantially Equivalent	Instrumentarium Corp.
K992644	SIDEXIS DIGITAL RADIOGRAPHY IMAGING SYSTEM	Aug 23, 1999	Substantially Equivalent	Sirona Dental Systems GmbH
K990087	DMD DIGITAL X-RAY SYSTEM	May 13, 1999	Substantially Equivalent	Dental/Medical Diagnostic Systems, Inc.
K990528	ORTHOPHOS 3/3 CEPH/3 DS	Apr 30, 1999	Substantially Equivalent	Sirona Dental Systems GmbH
K990002	QUICKRAY DSX 730	Apr 01, 1999	Substantially Equivalent	Julie Alliance
K990049	CD-DENT DIGITAL IMAGING DEVICES FOR DENTAL X-RAY SYSTEMS, MODELS 600, 1000 AND 2000	Mar 12, 1999	Substantially Equivalent	Digident , Ltd.
K983267	DIGORA FOR WINDOWS 2.0	Dec 30, 1998	Substantially Equivalent	Orion Corporation Soredex
K983283	SIGNET DXIS DIRECT X-RAY IMAGING SYSTEM	Nov 06, 1998	Substantially Equivalent	Signet Radiology, Inc.
K983057	ORTHOPHOS 5/PLUS/CD	Oct 22, 1998	Substantially Equivalent	Sirona Dental Systems GmbH