Dental Device Guide
Add your company

Diagnostic devices · 21 CFR 872 Subpart B

Digital Extraoral Source X-Ray System

FDA device type “System, X-Ray, Extraoral Source, Digital”.

FDA codeMUHClass221 CFR872.1800Pathway510(k)CategoryDental X-ray units
Companies listing it
8353 makers
Brands and models
259
510(k) clearances
20728 in five years
FDA name
System, X-Ray, Extraoral Source, Digital
1998: 31999: 62000: 62001: 62002: 62003: 52004: 82005: 22006: 152007: 112008: 82009: 92010: 92011: 102012: 92013: 92014: 82015: 122016: 62017: 92018: 32019: 52020: 52021: 102022: 72023: 112024: 42025: 32026: 219801990200020102020

510(k) clearances per year, 1976–2026

Companies that list MUH

83 companies currently list this device type with FDA.

CompanyCountryRoleBrands and models listedClearancesLatest
Dentsply Sirona, Inc.United StatesMaker—1482026
Ray Co., Ltd,South KoreaMakerRAYSCAN ?-OCL · RAYSCAN ?-OCS · RAYSCAN ?-P · RAYSCAN ?-SC · +3212026
Guilin Woodpecker Medical Instrument Co., Ltd.ChinaMakerDigital Intraoral X-Ray Imaging System · i-Scan Imaging Plate Scanner · i-Sensor H1; i-Sensor H2 · i-Sensor1.5 · +1122025
VATECH Co., Ltd.South KoreaMakerVistaPano S 2 (Model: VistaPano S) · VistaPano S Ceph 2 (Model: VistaPano S Ceph)332026
Cefla S.C.ItalyMakerEOS Compact · hyperion X5 · hyperion X9 pro · NewTom DCiS · +13152026
Genoray Co., Ltd.South KoreaMakerGenX-CR · GT300 · GT300-C · PAPAYA · +4142025
Qpix Solutions, Inc.United StatesMakerEzSensor HD (IOS-U10IF) · EzSensor HD (IOS-U15IF) · EzSensor HD (IOS-U20IF, IOS-U15IF, IOS-U10IF) · EzSensor HD (IOS-U20IF) · +142026
Changzhou Sifary Medical Technology Co., Ltd.ChinaMakerDental Sensors NanoPix1, NanoPix2, NanoPix1.5, Brand: Eighteeth · Dental Sensors V-Sensor1, V-Sensor242026
Satelec - Acteon GroupUnited StatesMakerPSPIX2 · SOPIX · SOPIX 2 · SOPIX INSIDE, SOPIX2 INSIDE · +3182024
PaloDEx Group OyFinlandMakerDIGORA Optime92024
Handpiece HeadquartersUnited StatesMakerCarina · GEM72024
Durr Dental SEGermanyMakerScanX Classic View · ScanX Edge · ScanX Intraoral View · ScanX Swift 2 · +462023
Alliage S/A Industrias Medico OdontologicaBrazilMakerD700 SLIM · EAGLE S · EVOLVE SENSOR · SAEVO SLIM32024
Dental Imaging Technologies CorporationUnited StatesMakerDEXIS IXS Size 1 · DEXIS IXS Size 1 Intraoral Sensor · DEXIS IXS Size 2 · DEXIS IXS Size 2 Intraoral Sensor · +222026
Fussen Technology Co., LtdChinaMakerDigital Intraoral Imaging Plate System22026
Shenzhen Xpectvision Technology Co., Ltd.ChinaMakerXVD2121 Plus · XVD253022024
PICOPACK Inc.South KoreaMakerMDP · WeSensor22024
Planmeca OyFinlandMakerPlanmeca ProMax · Planmeca ProMax 3D · Planmeca ProMax 3D Mid · Planmeca ProMax 3D Plus · +1252023
Midmark CorporationUnited StatesMakerMidmark Intraoral Digital Sensor · PROGENY IMAGING SOFTWARE72025
De Götzen S.R.L.ItalyMakerU-SENSE · U-SENSE HD · X-MIND optima · X-MIND optima 3D · +362023
Hdx Will Corp.South KoreaMakerDENTIOIII series (DENTIOIII, DENTIOIII-S)62021
Trident SRLItalyMakerBlu · Blu size 2 · BOOM sensor · BOOM sensor size 2 · +1152023
Rayence Co., Ltd.South KoreaMaker—52022
Dentium Co.,Ltd(ICT branch)South KoreaMakerIOX1 · IOX232023
Jiangsu Dynamic Medical Technology Co., LtdChinaMakerDigital image scanner of dental12023
Shanghai Handy Medical Equipment Co., Ltd.ChinaMakerHDR Sensor · HDR-361 · HDR-46112022
SOTA Cloud CorporationUnited StatesMakerSOTA Cloud Smart Sensor12026
Zinnovi Inc.United StatesMakerDUO1, DUO212024
Duerr Dental SEUnited StatesMakerScanX Duo -D1000A, D1000J, D1000T, D1000K · ScanX Duo Touch: J1200 · ScanX Intraoral - F3605, F3600T · ScanX Swift - G8000 · +1142019
Carestream Dental LLCUnited StatesMakerCS 2500P · CS 6200 · CS 7200 · CS 7600 · +15112020
Takara Belmont CorporationJapanMaker097 Bel-Ray II72017
The Yoshida Dental Mfg. Co., Ltd.JapanMakerImageWorks Panoura · Panoura 18S · Panoura X-ERA · X-era Smart62019
Rolence Ent., Inc.TaiwanMakerExtraoral X-Ray Unit · Intraoral Digital X-Ray Sensor52009
Dexcowin Co., Ltd.South KoreaMakerADX 4000 · Cocoon DX-7017 · Cocoon DX-7020 · COCOON SOLO (DX-7020s) · +542017
Sota Precision Optics, Inc.United StatesMakerClio Pedo · Clio Prime22006
Athlos OyFinlandMakerAthlos-1 · Athlos-Air · DC-Air™12021
Jazz ImagingUnited StatesMakerMinor · Solo12017
Cleartooth Electronics, Inc.United StatesMakerCleartooth Digital X-Ray12003
Nical SpaItalyMakerNICAL SMART MICRO, NSM1001AA,NPR1000AA, NPR1000VE.12015
PointImplant Co LtdSouth KoreaMaker———
Beyes Dental IncCanadaMakerDURAY ART PLUS Pan/Ceph · Duray Imaging Plate Scanner, Model:DC1 · Duray Intraoral Sensor, Model: DS1; DS2——
J. Morita MFG Corp.JapanMakerMODEL XDP1 · Veraview FX800 Model X800N · VERAVIEW IC 5 · Veraview X800 · +1——
Onvet Medical Canada Inc.CanadaMakerIntraoral Sensor, Size 1, Size 2——
XLINE S.r.l.ItalyMakerFONA ART Plus · FONA ART Plus C · FONA XPan DG · FONA XPan DG Plus · +7——
DIGIRAY Corp.South KoreaMakerClearVision CR · CR500 · Dental CR · EAI DxScan · +7——
Dhef Inc.TaiwanMaker———
iRay GroupChinaMakerCS 6200 Digital Intraoral X-Ray Sensor · Pluto0000X Digital Intraoral X-ray Imaging System · Pluto0001X Digital Intraoral X-ray Imaging System · Pluto0002X Digital Intraoral X-ray Imaging System · +2——
SMK Imaging LLCUnited StatesMakerEVA Select · EVA Select Digital Dental Imaging System · EVA SELECT DIRECT · EVA SELECT DIRECT SIZE #1 · +3——
iRay Imaging Technology Taicang LimitedChinaMakerCS 6200 Digital Intraoral X-Ray Sensor · Pluto0002XW · PlutoX Digital Intraoral X-ray Imaging System——
Carestream Healthcare International Company LimitedChinaMakerCS 7200; CS 7600; CS 7600 SCAN&GO DEVICE; CS 7600 SLOT PANEL——
iRay Korea LimitedSouth KoreaMakerPluto0001X · Pluto0002X——
Kashmir Surgical WorksIndiaMakerDental RVG——
Cyber Medical Imaging, Inc.United StatesMakerXDR CLARITY——
Nobel Biocare Services AGSwitzerlandContract manufacturerDEXIS Titanium, KaVo IXS HD942026
Young Innovations IncUnited StatesContract manufacturerPanoramic232025
DentiMax LLC / ArnettUnited StatesRepacker / relabelerDentiMax · OpenSensor32025
Ningbo Runyes Medical Instrument Co., Ltd.ChinaForeign exporterRunyes Dental Digital Imaging Sensor22026
Remedi Inc.South KoreaManufacturerR-Sensor22024
CAO Group, Inc.United StatesContract manufacturerAcuity Direct X-Ray Photon Detection132020
DentamericaUnited StatesRepacker / relabelerAPIXIA DIGIREX42010
Vector Research & DevelopmentUnited StatesRepacker / relabelerMaxRay12002
Masterlink, LLC.United StatesRepacker / relabelerApex Dental Sensor 1 · Apex Dental Sensor 212017
Apixia, Inc.United StatesRepacker / relabeler—12012
Jersey Dental SuppliesUnited StatesRepacker / relabelerDEXIS SENSOR——
TitanLinks Logistics LLCUnited StatesRepacker / relabelerdental xray · XRay——
Jmu Dental, Inc.United StatesRepacker / relabelerImaging Plate Scanner · X-Ray Sensors——
Soher Med LimitedHong Kong SAR ChinaForeign exporterxray accessory——
GoldenDentUnited StatesRepacker / relabelerX-Ray——
Flight Dental Systems USA Inc.United StatesRepacker / relabelerX-Vision Portable Handheld X-Ray · XR-3800, XR-3801, XR-3802——
Yizur LtdHong Kong SAR ChinaForeign exporterxray——
Ray America Inc.United StatesListerCocoon Portable Handheld X-Ray System · RAYSCAN ?-Expert · RIOSCAN——
Ads Dental System Inc.United StatesRemanufacturerPlutoX Digital Intraoral X-ray Imaging System——
Toyo Medical Co.United StatesRepacker / relabelerTakara Belmont Co · Toyo Medical Co.——
Owandy Radiology SASFranceRepacker / relabelerI-MAX · I-MAX 3D · I-MAX Touch · I-MAX Touch 3D · +4——
Sanicure BVNetherlandsForeign exporter———
Zapalign LLCUnited StatesRepacker / relabeler———
Peter Brasseler Holdings, LLCUnited StatesContract manufacturer———
Xtechdental Inc.United StatesListerDigital Intraoral Imaging Plate System · F200 IMAGE PLATE SYSTEM——
LBN Medical ApSDenmarkForeign exporterXW8000 Workstation——
Orich Medical Equipment (Tianjin) Co., Ltd.ChinaForeign exporterPanaramic——
Genoray America Inc.United StatesRepacker / relabelerPAPAYA 3D Plus · PAPAYA Plus——
Mainline Medical Dental SupplyCanadaForeign exporter———
Oketz Logistics LLCUnited StatesRepacker / relabeler———

510(k) clearances

Decided510(k)DeviceApplicant
30 Sep 2026K261663EzSensor HDQpix Solutions, Inc.
3 Mar 2026K251793SOTA Cloud Smart Sensor (1.5)SOTA Cloud Corporation
10 Nov 2025K252570EzSensor HD, EzSensor UHDQpix Solutions, Inc.
24 Oct 2025K250687Cocoon Solo (DX-7020s)Dexcowin Global, Inc.
24 Sep 2025K251206Digital X-Ray DentiMax Pro Imaging SystemDentiMax LLC / Arnett
25 Oct 2024K240040VistaPano 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)VATECH Co., Ltd.
11 Oct 2024K242778X Sensor (Model: IOS-A15IF, HDI-15DGF)Qpix Solutions, Inc.
5 Jul 2024K241649DUO1 and DUO2Zinnovi Inc.
18 Apr 2024K232325RAYSCAN a-ExpertRay Co., Ltd,
20 Dec 2023K231660Digital image scanner of dentalJiangsu Dynamic Medical Technology Co., Ltd
21 Nov 2023K233053DEXIS Ti2 Intraoral Sensor, DEXIS IXS Size 1 Intraoral Sensor, DEXIS IXS Size 2 Intraoral SensorDental Imaging Technologies Corporation
20 Oct 2023K232552TuxDeluxe (Size 1 6100B, Size 2 6101B)Tuxedo Imaging, LLC
20 Oct 2023K230998Digital Wireless Intraoral X-Ray SensoriRay Imaging Technology (Haining) Limited
10 Oct 2023K230916WeSensorPICOPACK Inc.
27 Sep 2023K232255EZSensor XHDQpix Solutions, Inc.
13 Sep 2023K232158GenX-CRGenoray Co., Ltd.
22 Jun 2023K231202QuickRayPRODenterprise International, Inc
21 Apr 2023K230811Digital Intraoral X-Ray SensoriRay Imaging Technology (Haining) Limited
11 Apr 2023K230732Eagle S/Saevo Slim/D700 SlimAlliage S/A Industrias Medica Odontológico.
6 Feb 2023K230095ScanX Swift 2.0, ScanX Swift View 2.0Durr Dental SE
31 Aug 2022K221955Brasseler GEM, Brasseler GEM10, Brasseler GEM15, Brasseler GEM20Realcloud Imaging Inc. Dba Realcloud Imaging
22 Jun 2022K221008HDR Sensor- HDR361 (Size 1), HDR Sensor- HDR461 (Size 2)Shanghai Handy Medical Equipment Co., Ltd.
19 May 2022K220423PAPAYA & PAPAYA PlusGenoray Co., Ltd.
13 Apr 2022K220556OpenSensorX SeriesDentiMax LLC / Arnett
11 Mar 2022K220422Dental sensors NanoPix1, NanoPix2Iray Technology Taicang , Ltd.
2 Mar 2022K214091Dental Image Plate Scanner, Model DFC-4T-SMARTHefei Dentafilm Medical Equipment Co., Ltd.
17 Feb 2022K220277Digital Intraoral X-ray SensorShenzhen Xpectvision Technology Co., Ltd.
10 Dec 2021K213637JAZZ Solo sensorJazz Imaging, LLC Dba Jazz Imaging
7 Oct 2021K212279Digital Intraoral X-ray Imaging SystemIray Technology Taicang , Ltd.
27 Sep 2021K212080Imaging Plate Scanner, i-ScanGuilin Woodpecker Medical Instrument Co., Ltd.
15 Sep 2021K202369RXS 1000Rolence Enterprise, Inc.
30 Aug 2021K212103StarX-1, StarX-2, StarX PRO-1 and StarX PRO-2Fona S.R.L
29 Jul 2021K211317CRUXVIEWCruxell Corp.
22 Jul 2021K211688DC-Air and Athlos-1 and Athlos-AirAthlos Oy
23 Apr 2021K210312PlutoX Digital Intraoral X-Ray Imaging SystemIray Technology Taicang , Ltd.
19 Mar 2021K203116SensorXDurr Dental SE
5 Feb 2021K203374X-MIND prime (under trade mark Acteon), I-MAX (under trade mark Owandy Radiology)De Götzen S.R.L.
6 Nov 2020K202664Clio Prime and Clio PedoSota Precision Optics, Inc. Dba Sota Imaging
7 Oct 2020K202633ScanX EdgeDurr Dental SE
15 Apr 2020K200625I-View Gold and Imagen Gold Dental SensorsTrident SRL
28 Feb 2020K200284R-Sensor, R-SensorRemedi Inc.
20 Feb 2020K191719X-MIND TriumDe Götzen S.R.L.
5 Dec 2019K192766Digital Intraoral Imaging Plate SystemFsusen Technology Co., Ltd.
21 Aug 2019K191623ScanX Touch/ScanX Duo TouchDuerr Dental SE
1 Mar 2019K190234ODI HD Dental SensorCnd Global Technologies, Inc.
12 Feb 2019K183637Cruxcan (CRX-1000)Cruxell Corp.
31 Jan 2019K182198Panoura X-ERA PF/NF/MFThe Yoshida Dental Mfg. Co., Ltd.
21 Nov 2018K181297DENTIOIII series (DENTIOIII, DENTIOIII-S)Hdx Will Corp.
20 Jul 2018K181636AuroraSodium Systems, LLC
20 Jun 2018K181358Televere Digital Dental Imaging SystemTelevere Systems, Inc.
19 Dec 2017K173646FS ErgoPaloDEx Group Oy
18 Dec 2017K172918DEXIS Titanium, KaVo IXS HD (Size 1, Size 2)KaVo North America
26 Oct 2017K173046Cocoon Portable Handheld X-Ray SystemDexcowin Co., Ltd.
6 Jul 2017K162190Rotograph Prime (under trade mark Villa Sistemi Medicali), I-MAX (under trade mark Owandy Radiology)Villa Sistemi Medicali S.P.A.
1 May 2017K170733ScanX Intraoral ViewDuerr Dental AG
4 Apr 2017K170731System, X-Ray, Extra oral Source, Digital, PaX-i Plus, PaX-i InsightVATECH Co., Ltd.
20 Mar 2017K163175Bel-Cypher ProTakara Belmont Corporation
9 Mar 2017K163224JAZZ SOLO SensorJazz Imaging
28 Feb 2017K163282Apex Dental SensorsMasterlink, LLC.
4 Nov 2016K162619I View and Imagen SensorTrident SRL
4 Nov 2016K162585SuniIQ Digital Radiography SystemSuni Medical Imaging, Inc.
3 Nov 2016K161131FONA Pan/CephFona S.R.L
15 Apr 2016K160788RIOScan (RPS500)Ray Co., Ltd,
10 Mar 2016K160386ReadeR, VieweR, QuickScan PSPTrident SRL
10 Feb 2016K153144TIO-H DIGITAL RADIOGRAPHY SENSORDenttio, Inc.
24 Dec 2015K152162Myray- HYPERION X5Cefla S.C.
14 Dec 2015K151926QuickRay HD Intraoral SensorDenterprise International, Inc
10 Nov 2015K153060Digital Dental Intra Oral Sensor, EzSensor Classic, EzSensor HD, HDI-P, HDI-SRayence Co., Ltd.
26 Aug 2015K150823EDLENi Intra-Oral SensorEdlen Imaging, LLC
21 Aug 2015K151087CS 8100SC, CS8100SC AccessCarestream Dental LLC
17 Aug 2015K142995SOPIXSopro - Acteon Group
31 Jul 2015K151053PSPIX 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 scannerSopro - Acteon Group
19 Jul 2015K151707EzSensor Soft, EzSensor Soft i, EzSensor Bio, and EzSensor Bio iRayence Co., Ltd.
1 May 2015K150797Digital Dental Intra Oral Sensor, EzSensor SmartRayence Co., Ltd.
22 Apr 2015K142058RAYSCAN A-EXPERTRay Co., Ltd,
18 Mar 2015K143703NICAL SMART MICRO CR system for intraoral dental imagesNical Spa
10 Mar 2015K143753Digital Dental Intra Oral Sensor, EzSensor Soft, EzSensor BioRayence Co., Ltd.
31 Oct 2014K141700PAPAYA PLUS, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEMGenoray Co., Ltd.
5 Sep 2014K140013SOPIX INSIDE, SOPIX2 INSIDESopro - Acteon Group
30 Jul 2014K141130ENCOMPASSPanoramic Corp.
13 May 2014K133206Z-RAY INTRA-ORAL DIGITAL RADIOGRAPHY SYSTEMZuma Dental, LLC
9 May 2014K134055ADX4000WDexcowin Co., Ltd.
28 Apr 2014K133271OPTEO, VIDEOGRAPH HDOwandy
24 Apr 2014K133007DX3000-LDexcowin Co., Ltd.
20 Mar 2014K133231DIGORA OPTIMEInstrumentarium Dental, Palodex Group OY
6 Nov 2013K130419PAPAYA PLUS, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEMGenoray Co., Ltd.
1 Nov 2013K131693RAYSCAN A-EXPERTRay Co., Ltd,
6 Sep 2013K131442FIRECR DENTALIMAGING SYSTEM3DISC Americas
18 Jul 2013K130088PORT VIEW, DIGITAL X-RAY SENSOR SYSTEMGenoray Co., Ltd.
15 Jul 2013K130585PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM, PAX-I DIGITAL EXTRAORAL SOURCE X-RAY SYSTEMVATECH Co., Ltd.
15 Mar 2013K122918RAYSCAN A-EXPERTRay Co., Ltd,
8 Mar 2013K122806IMAGE WORKS PANOURAMic International
24 Jan 2013K121800POINT 500 HD POINT500C HDPointnix Co., Ltd.
7 Jan 2013K122643VANTAGE MODEL V5000, V5100, V5000C, V5100CMidmark Corporation
27 Dec 2012K123419EVA SELECT DIGITAL DENTAL IMAGING SYSTEMAfp Imaging Corp.
4 Sep 2012K122155PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM PAX-I DIGITAL EXTRAORAL SOURCE X-RAY SYSTEMVATECH Co., Ltd.
10 Jul 2012K120263VOLUX 21C, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEMGenoray Co., Ltd.
22 Jun 2012K120975CS 8100 CS 8100 ACCESSCarestream Dental LLC
7 May 2012K120106APIXIA DIGIREX DIGITAL DENTAL REDIOGRAPHY SYSTEMApixia, Inc.
27 Mar 2012K113672PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEMVATECH Co., Ltd.
6 Mar 2012K120318VIVI ERGON-X HFVivi S.R.L.
17 Jan 2012K113497HYPERIONCefla S.C. Cefla Dental Group
5 Jan 2012K111103DIGITAL X-RAY IMAGING SYSTEMRf Co., Ltd.
15 Dec 2011K102456INTRAORAL BELSENSOR GOLDTakara Belmont USA, Inc.
22 Nov 2011K112380CLEARVISIONMidmark Corporation
23 Sep 2011K111649CS 7600Carestream Health, Inc.
19 Sep 2011K103290EDLEN IMAGING - GEMINI DUSBEdlen Imaging, LLC
22 Jul 2011K111152ROTOGRAPH EVO 3DVilla Sistemi Medicali S.P.A.
13 Jul 2011K111231PANOURA 18SThe Yoshida Dental Mfg. Co., Ltd.
20 Apr 2011K110768COMPUTED DENTAL RADIOGRAPHYSchick Technologies, Inc.
17 Mar 2011K110371ENCOMPASS HF100- EAGLE PANORAMIC/CEPHALOMETRIC X-RAYPanoramic Corp.
17 Mar 2011K103689PLANMECA PROMAX 3D MIDPlanmeca Oy
17 Feb 2011K110160BEL-CYPHER NTakara Belmont Corporation
22 Oct 2010K102124DENTAL COMPUTED TOMOGRAPHY X-RAY SYSTEMVATECH Co., Ltd.
21 Oct 2010K100960WDS X-POD AND ZEN-X DIGITAL X-RAY SENSORSCefla Dental Group
6 Oct 2010K093683ORTHOPANTOMOGRAPH OP300Instrumentarium Dental, Palodex Group OY
16 Sep 2010K101661MYRAY HYPERIONCefla Dental Group
20 Jul 2010K092329SOPIX 2Satelec - Acteon Group
12 May 2010K093590PLANMECA PROMAX 3D MAXPlanmeca Oy
26 Apr 2010K093478KODAK RVG 6500 SYSTEM AND KODAK RVG 6500 IPS SYSTEMCarestream Dental LLC
26 Apr 2010K092171VOLUX, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEMGenoray Co., Ltd.
24 Mar 2010K100317DIGITAL X-RAY IMAGING SYSTEM (PAX-PRIMO) MODEL PAX-PRIMOVATECH Co., Ltd.
2 Dec 2009K090526MEDICAL IMAGE PROCESSING UNIT, MODEL EZSENSORE-Woo Technology
20 Nov 2009K092591ORTHOPANTOMOGRAPH OP30Instrumentarium Dental, Palodex Group OY
30 Oct 2009K092547DENTIMAX DIGITAL X-RAY IMAGING SYSTEM SENSOR SIZE 1, 2, DENTIMAX USB CONTROL BOXDentiMax LLC / Arnett
27 Aug 2009K092537DIGITAL X-RAY SENSOR, MODEL E9539,E9505,E9502, E9540Toshiba America Electronic Components, Inc.
20 Jul 2009K091866PROGENY VANTAGE PANORAMIC X-RAY SYSTEMMidmark Corporation
2 Jun 2009K083057I-MAX TOUCHOwandy
28 May 2009K090458DEXIS SENSORDexis, LLC
13 Mar 2009K090020BEL-CYPHER, MODEL Y977Takara Belmont Corporation
10 Mar 2009K083532ADX4000-L, DX3000-LDexcowin Co., Ltd.
5 Dec 2008K082972KODAK 9500Carestream Dental LLC
6 Nov 2008K081088MYRAY SKYVIEWCefla S.C.
2 Sep 2008K081925SNAPSHOTInstrumentarium Dental, Palodex Group OY
26 Aug 2008K081903XIOS PLUS WALL-MODULEDentsply Sirona, Inc.
29 Apr 2008K080889KODAK 9000C EXTRAORAL IMAGING SYSTEMCarestream Dental LLC
8 Apr 2008K073696VERAVIEWEPOCSJ. Morita USA, Inc.
8 Apr 2008K073365DENTAL DIGITAL X-RAY IMAGING SYSTEMVATECH Co., Ltd.
11 Feb 2008K073435KODAK 9000, KODAK 9000 3DCarestream Dental LLC
19 Dec 2007K073350SCANORA 3DSoredex Palodex Group OY
2 Nov 2007K072134SCHICK COMPUTED ORAL RADIOLOGY SYSTEMSchick Technologies, Inc.
21 Sep 2007K072244PLANMECA PROONEPlanmeca Oy
18 Sep 2007K072357NEWTOM VG COMPUTED TOMOGRAPHY X-RAY SYSTEMAfp Imaging Corp.
5 Jul 2007K070811CORDLESS PORTABLE DENTAL X-RAY SYSTEM, MODEL ADX4000Dexco
2 Jul 2007K063837SIGMA MInstrumentarium Dental, Palodex Group OY
26 Apr 2007K070664PROGENY IMAGING SOFTWARE, MODEL# 500-405 (6,7,8).Progeny, Inc.
24 Apr 2007K070535RETROPAN CCD-TWAIN-USBVideo Dental Concepts, Inc.
5 Apr 2007K070505KRYSTAL-X WIFIOwandy
27 Mar 2007K070304DIGORA PCT/DIGIPODSoredex Palodex Group OY
7 Feb 2007K070219SUNIRAY II DIGITAL RADIOGRAPHY SYSTEMSuni Medical Imaging, Inc.
26 Dec 2006K063459CRANEX NOVUSSoredex Palodex Group OY
14 Nov 2006K062403IMAX CEPH DIGITAL X-RAY SENSOROwandy
5 Oct 2006K062529BELMAX CM MODEL X168Takara Belmont USA, Inc.
3 Jul 2006K061284I-CAT SCANNERImaging Sciences Intl., Inc.
9 Jun 2006K053172UNIVERSAL-X (USA) OR /KRYSTAL-X (EUROPE)Owandy
6 Jun 2006K061114WDS, SIZE 2 AND SIZE 2Cefla S.C.R.L.
14 Apr 2006K060892GALILEOSDentsply Sirona, Inc.
15 Mar 2006K060328PLANMECA PROMAX 3DPlanmeca Oy
10 Mar 2006K060178VIX WIN PROGendex Dental Systems
17 Feb 2006K053558CEPH, MODEL 4900Schick Technologies, Inc.
8 Feb 2006K060179BIO-RAY SDX DIGITAL X-RAY SYSTEMSigma Biomedics, Inc.
8 Feb 2006K060079KODAK MODEL CR-7400 DIGITAL RADIOGRAPHY SYSTEMEastman Kodak Company
3 Feb 2006K060149SUNIPAN IMAGING SYSTEM & ACCESSORIESSuni Medical Imaging, Inc.
12 Jan 2006K053221CDMX-HCamsight Co., Inc.
6 Jan 2006K053220VERAVIEW IC 5, MODEL XDP1J. Morita USA, Inc.
20 Jul 2005K051664SCAN300FP / RETROPAN (VDC)Oy Ajat, Ltd.
26 May 2005K050693ACCENTDuerr Dental SE
3 Dec 2004K041834ADR PLUS SSXI IMAGING DEVICE FOR X-RAY SYSTEMS SUCH AS X-CALIBER, X-CALIBER CM, ANA-BEL AND ANA-BEL CMTakara Belmont USA, Inc.
13 Oct 2004K042736CDX DIGITAL X-RAY IMAGING SYSTEMCnc Imaging, Inc.
4 Oct 2004K042372HDS INTRA-ORAL IMAGING SYSTEMVatech Value Added Technology Co., Ltd.
30 Aug 2004K041120EV APAN DIGITAL, MODEL K1VSM2000Afp Imaging Corp.
9 Aug 2004K041831PROGENY MPSE INTRAORAL DENTAL X-RAY SENSORProgeny, Inc.
29 Jun 2004K041580IMAGERAYIHenry Schein, Inc.
15 Jun 2004K041050DIGORA OPTIME (OR DIGORA ONTIME)Soredex Palodex Group OY
1 Apr 2004K024186X-VIEWSometech Corporation
30 Dec 2003K033147CLEARTOOTH DIGITAL X-RAY SYSTEMCleartooth Electronics, Inc.
20 Oct 2003K033248HITACHI CB MERCURAY DENTAL CONE-BEAM X-RAY SYSTEMHitachi Medical Systems America, Inc.
11 Sep 2003K031801PANTOS, MODELS: PANTOS 16, AND PANTOS DGBlue X Imaging Srl
5 May 2003K031291CDR PANX, MODEL 4792Schick Technologies, Inc.
3 Jan 2003K023346TROPHYPANTrophy Radiologie
13 Dec 2002K023292APEX HRI DIGITAL RADIOGRAPHY SYSTEMKrugman Technologies, Inc.
2 Oct 2002K022953MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEMSchick Technologies, Inc.
15 Aug 2002K021718INTRAORAL IMAGING SYSTEM, MODEL SUNI-RAYSuni Imaging Microsystems, Inc.
6 Aug 2002K021542ADC DENTALAgfa Corp.
13 Jun 2002K020588X-IMAGE DIGITAL X-RAY SYSTEMEscape Technology, Inc.
1 Feb 2002K013893SCANXDuerr Dental SE
21 Dec 2001K012514DIGIPAN / DPITrophy Radiologie
13 Dec 2001K013271DXS DIGITAL X-RAY SYSTEMDouglas C. Yoon, Dds
6 Dec 2001K013659MODIFICATION TO SIDEXIS DIGITAL RADIOGRAPHY IMAGING SYSTEMDentsply Sirona, Inc.
6 Dec 2001K013650ORTHOPHOS DS/DC CEPH, ORTHOPHOS 5/PLUS/CDDentsply Sirona, Inc.
10 Aug 2001K012170DIGORA PCTSoredex Palodex Group OY
21 May 2001K010915CDMXCamsight Co., Inc.
21 Dec 2000K002425MEDIADENT HDX/MMD HDX SP XRAY SENSORMulti Media Dental Systems, Inc.
2 Aug 2000K001928SIGMAInstrumentarium Imaging, Inc.
22 Jun 2000K001439ORTHOCEPH OC100 DInstrumentarium Corp.
31 Mar 2000K992392RTLXInfimed, Inc.
31 Mar 2000K000454DIMEX 2Planmeca Oy
14 Feb 2000K993958IDX-60 INTRAORAL X-RAYX-Cel X-Ray Corp.
28 Sep 1999K992385ORTHOPANTOMOGRAPH OP100DInstrumentarium Corp.
23 Aug 1999K992644SIDEXIS DIGITAL RADIOGRAPHY IMAGING SYSTEMDentsply Sirona, Inc.

Showing the 200 most recent of 207.

Official records: FDA product classification for MUH · 21 CFR 872.1800.

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026