FDA Product Code
FDA Product Code EHD — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Dental
- 21 CFR Citation
- 872.1800
510(k) Clearances — 191 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260795 | Hand-held Dental X-ray System (HyperLight-M) | Changzhou Sifary Medical Technology Co., Ltd. | 2026-09-14 | Traditional | PDF ↗ |
| K260367 | Portable Dental X-ray System Model PDX nova | PDX Co., Ltd. | 2026-05-27 | Traditional | PDF ↗ |
| K253864 | NOMAD Pro 3 | Dental Imaging Technologies Corporation | 2026-03-20 | Traditional | PDF ↗ |
| K252110 | Dental X-RAY Unit (AJX200) | Guangzhou Ajax Medical Equipment Co., Ltd. | 2026-03-12 | Traditional | PDF ↗ |
| K254018 | Portable Dental X-ray Device (GT-1) | Guilin Refine Medical Instrument Co., Ltd. | 2026-02-19 | Traditional | PDF ↗ |
| K252909 | Diagnostic X-Ray Equipment Model POCT22 | Ningbo Runyes Medical Instrument Co., Ltd. | 2026-02-03 | Traditional | PDF ↗ |
| K251438 | Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray ) | Guilin Woodpecker Medical Instrument Co., Ltd. | 2025-09-04 | Special | PDF ↗ |
| K242185 | Rextar Pro | Raypia Co., Ltd. | 2024-12-04 | Traditional | PDF ↗ |
| K242591 | XERO-alpha | DRTECH Corporation | 2024-11-01 | Traditional | PDF ↗ |
| K241963 | WERAY | Picopack Co., Ltd. | 2024-07-30 | Traditional | PDF ↗ |
| K241305 | LifeRay Intraoral Handheld X-ray System | Lucas Lifecare | 2024-07-05 | Traditional | PDF ↗ |
| K240759 | REMEX-GR100 | Remedi Co., Ltd. | 2024-05-13 | Traditional | PDF ↗ |
| K233914 | XVbeam2000 | Shenzhen Xpectvision Technology Co., Ltd. | 2024-02-08 | Traditional | PDF ↗ |
| K233395 | Portable Dental X-Ray (AXR60 S); Portable Dental X-Ray (AXR65 S) | Alliage S/A Industrias Médico Odontológica | 2024-01-03 | Abbreviated | PDF ↗ |
| K231055 | x-mind dc (under trademark Acteon), Owandy-RX DC (under trademark OwandyRadiology) | De Götzen S.R.L. | 2023-12-28 | Abbreviated | PDF ↗ |
| K232085 | DVAS (DVAS-M, DVAS-W) | Genoray Co., Ltd. | 2023-12-08 | Traditional | PDF ↗ |
| K232012 | N1 | Osstem Implant Co., Ltd. | 2023-11-28 | Traditional | PDF ↗ |
| K232068 | HyperLight Portable X-ray Unit | Changzhou Sifary Medical Technology Co., Ltd. | 2023-09-01 | Traditional | PDF ↗ |
| K231449 | Portable X-ray System Model Ray98(P) | Ningbo Runyes Medical Instrument Co., Ltd. | 2023-07-13 | Traditional | PDF ↗ |
| K223780 | Lumos 3DX | 3Dio | 2023-07-06 | Traditional | PDF ↗ |
| K221587 | DHX-70H, XTG-70H | Digimed Co., Ltd. | 2023-03-03 | Traditional | PDF ↗ |
| K223010 | Portable X-ray System | Iray Technology Taicang , Ltd. | 2023-01-17 | Traditional | PDF ↗ |
| K222569 | Ai Ray Dental X-Ray Device | Guilin Woodpecker Medical Instrument Co., Ltd. | 2022-11-23 | Traditional | PDF ↗ |
| K223058 | EzRay Air 2 Wall (Model: VEX-S350W) | VATECH Co., Ltd. | 2022-10-26 | Special | PDF ↗ |
| K220579 | Hybrid C70 | Digimed Co., Ltd. | 2022-09-01 | Traditional | PDF ↗ |
| K222274 | FONA XDC | Fona S.R.L | 2022-08-23 | Special | PDF ↗ |
| K221286 | CLAROX | Vsi Co., Ltd. | 2022-06-29 | Traditional | PDF ↗ |
| K221233 | DT-703 | Ecotron Co., Ltd. | 2022-06-27 | Traditional | PDF ↗ |
| K220574 | HYBRID S70 | Digimed Co., Ltd. | 2022-04-22 | Traditional | PDF ↗ |
| K213282 | ERI Handheld Dental X-ray System (Model AG100) | Energy Resources International Co., Ltd. Hsinchu Branch | 2022-04-04 | Traditional | PDF ↗ |
| K211014 | Portray | Surround Medical Systems | 2021-07-28 | Traditional | PDF ↗ |
| K201800 | Portable Dental X-ray (NR-F350, CS 2400P, CS 2300P, R2 Port-X) | Nanoray Co., Ltd. | 2020-12-28 | Traditional | PDF ↗ |
| K200182 | EzRay Air Portable (Model: VEX-P300) | VATECH Co., Ltd. | 2020-02-11 | Special | PDF ↗ |
| K192700 | Xcam | Hdx Will Corp. | 2019-12-27 | Traditional | PDF ↗ |
| K190935 | EZER, Portable X-ray System | Livermoretech, Inc. | 2019-12-19 | Traditional | PDF ↗ |
| K180671 | MINE | Rht Co., Ltd. | 2019-06-05 | Traditional | PDF ↗ |
| K190357 | Star-X, Intraoral X-ray System | Hdx Will Corp. | 2019-03-15 | Traditional | PDF ↗ |
| K182206 | RiX70 DC | Trident S.R.L | 2018-09-13 | Traditional | PDF ↗ |
| K181891 | Portable X-ray System (Model: MiniX-V, Mini X-S) | Digimed Co., Ltd. | 2018-08-10 | Traditional | PDF ↗ |
| K180561 | MobileX Portable X-ray System | Denterprise International, Inc. | 2018-04-04 | Traditional | PDF ↗ |
| K172928 | Portable X-ray System | Rolence Enterprise, Inc. | 2018-03-16 | Traditional | PDF ↗ |
| K172810 | PORT-X IV | Genoray Co., Ltd. | 2018-03-07 | Traditional | PDF ↗ |
| K173319 | KaVo NOMAD Pro 2 Handheld X-ray System | Aribex | 2017-11-16 | Special | PDF ↗ |
| K170967 | Intraskan DC Plus | Skanray Technologies Private Limited | 2017-06-08 | Special | PDF ↗ |
| K163705 | EzRay Air W | VATECH Co., Ltd. | 2017-01-24 | Special | PDF ↗ |
| K163519 | RX DC | Cefla S.C. | 2017-01-13 | Traditional | PDF ↗ |
| K161063 | EzRay Air (Model VEX-P300) | VATECH Co., Ltd. | 2016-09-01 | Traditional | PDF ↗ |
| K160458 | BI IMAGE-X EVOLUTION | Radiotecnologia Industrial S.A. DE C.V. | 2016-06-20 | Traditional | PDF ↗ |
| K152859 | Portable X-ray System (Model: MINIX-V / MINIX-S) | Digimed Co., Ltd. (Digimed Corporation Until 31/12/2012) | 2015-12-03 | Traditional | PDF ↗ |
| K141293 | PHOT-X IIS MODEL 505 | Takara Belmont Corporation | 2014-09-03 | Traditional | PDF ↗ |
| K141497 | PORTABLE X-RAY SYSTEM (MODEL:EXARO,XRAY2GO) | Osstem Implant Co., Ltd. | 2014-08-26 | Special | PDF ↗ |
| K132378 | X-MIND UNITY | De Gotzen S.R.L. | 2014-05-30 | Abbreviated | PDF ↗ |
| K130109 | ENDOGRAPH DC | Villa Sistemi Medicali S.P.A. | 2013-08-01 | Abbreviated | PDF ↗ |
| K132041 | REXTAR X | Meta Biomed, Inc. | 2013-07-31 | Special | PDF ↗ |
| K122124 | PORTABLE X-RAY SYSTEM | Osstem Implant Co., Ltd. | 2013-05-16 | Traditional | PDF ↗ |
| K122016 | REXTAR, REXTAR LCD | Meta Biomed, Inc. | 2013-03-01 | Traditional | PDF ↗ |
| K123493 | VEX-S 100W INTRAORAL X-RAY SYSTEM | VATECH Co., Ltd. | 2012-12-13 | Special | PDF ↗ |
| K122582 | DENTAL X-RAY Z70 (W); DENTAL X-RAY Z70 (M); DENTAL X-RAY Z70 (C) | Denterprise International, Inc. | 2012-12-07 | Traditional | PDF ↗ |
| K111330 | AIR TECHNIQUES HIGH FREQUENCY INTRA-ORAL X-RAY | Skanray Technologies | 2011-05-27 | Traditional | PDF ↗ |
| K103600 | PORTABLE X-RAY SYSTEM | Digimed Corporation | 2011-04-08 | Traditional | PDF ↗ |
| K103579 | INTRA SKAN DC | Skanray Technologies | 2011-03-18 | Traditional | PDF ↗ |
| K093105 | VISTEO | Owandy | 2010-10-18 | Abbreviated | PDF ↗ |
| K091255 | MINXRAY, MODEL: BPD60 | Minxray, Inc. | 2010-05-12 | Traditional | PDF ↗ |
| K093240 | BELRAY II | Takara Belmont Corp. | 2010-03-22 | Traditional | PDF ↗ |
| K092772 | PORTABLE X-RAY SYSTEM, MODEL HAND-RAY | Hanjin Digi-X Co., Ltd. | 2010-01-06 | Traditional | PDF ↗ |
| K092103 | DENTAL EXTRAORAL SOURCE X-RAY SYSTEM (ESX) | VATECH Co., Ltd. | 2009-10-09 | Traditional | PDF ↗ |
| K091197 | PLANMECA PROSENSOR | Planmeca Oy | 2009-07-29 | Traditional | PDF ↗ |
| K090749 | ROOGRAPH EVO, MODEL 9307XY11Z1, ROTOGRAPH EVO D, MODEL 9307XY1191 | Villa Sistemi Medicali S.P.A. | 2009-05-18 | Abbreviated | PDF ↗ |
| K082875 | PORTABLE X-RAY SYSTEM, MODEL DXR -1 | Exaro Co., Ltd. | 2009-02-05 | Traditional | PDF ↗ |
| K083344 | HELIODENT PLUS | Sirona Dental Systems GmbH | 2008-12-23 | Traditional | PDF ↗ |
| K082167 | PORTABLE X-RAY SYSTEM, MODELS DIOX-602, PROX | Digimed Corporation | 2008-09-26 | Traditional | PDF ↗ |
| K081899 | ANYRAY PORTABLE X-RAY SYSTEM | E-Woo Technology Co., Ltd. | 2008-08-21 | Traditional | PDF ↗ |
| K081664 | NOMAD PRO X-RAY SYSTEM | Aribex, Inc. | 2008-06-23 | Traditional | PDF ↗ |
| K080076 | RX DC X-RAY UNIT | Cefla S.C.R.L. | 2008-03-14 | Traditional | PDF ↗ |
| K063121 | PORTABLE X-RAY SYSTEM, MODEL PORT-X II | Genoray Co., Ltd. | 2007-01-11 | Traditional | PDF ↗ |
| K060640 | DIGIREX DIGITAL DENTAL RADIOGRAPHY SYSTEM | Dentamerica | 2006-04-24 | Traditional | PDF ↗ |
| K060292 | KODAK MODELS 2100 AND 2200 | Kodak-Trophy | 2006-03-03 | Special | PDF ↗ |
| K051795 | NOMAD DENTAL X-RAY SYSTEM | Aribex, Inc. | 2005-07-14 | Traditional | PDF ↗ |
| K051464 | PLANMECA PROMAX WITH DEC (DYNAMIC EXPOSURE CONTROL) | Planmeca Oy | 2005-06-24 | Traditional | PDF ↗ |
| K050255 | ARTHORALIX 8500, MODELS 110-0199G1, 110-0199G2, 110-0199G3, 110-0199G4 | Gendex Dental Systems | 2005-03-17 | Traditional | PDF ↗ |
| K043104 | KODAK ORTHODONTIC IMAGING AND OMS IMAGING 8.0 | Practiceworks, Inc. | 2005-02-24 | Traditional | PDF ↗ |
| K043612 | ORTHOPANTOMOGRAPH OP200, OP200D, AND ORTHOCEPH OC200, OC200D | Instrumentarium Corp. Imaging Division | 2005-02-09 | Traditional | PDF ↗ |
| K050019 | IN EXAM INTRAORAL DENTAL X-RAY SYSTEM | Kavo America | 2005-01-31 | Traditional | PDF ↗ |
| K043557 | MODEL PC-1000 PANORAMIC/CEPHALOMETRIC X-RAY SYSTEMS | Panoramic Corp. | 2005-01-13 | Special | PDF ↗ |
| K043136 | ELITY 70 X-RAY | Dental X-Ray E.U. | 2005-01-06 | Traditional | PDF ↗ |
| K043307 | CRANEX D | Soredex Palodex Group OY | 2004-12-17 | Traditional | PDF ↗ |
| K043092 | PREVA, 76IN ARM, 66IN ARM, 56IN ARM, MODELS P7017, P7016, P7015 | Progeny, Inc. | 2004-12-13 | Traditional | PDF ↗ |
| K042260 | PHOT-X II, MODEL 303 | Takara Belmont USA, Inc. | 2004-09-07 | Traditional | PDF ↗ |
| K040382 | CRANEX BASEX D OR CRANEX EXCEL D | Soredex Palodex Group OY | 2004-07-13 | Traditional | PDF ↗ |
| K040748 | ANA-BEL, MODEL 087D AND ANA-BEL CM, MODEL 187-CM | Takara Belmont USA, Inc. | 2004-06-02 | Traditional | PDF ↗ |
| K033755 | MINRAY | Soredex Palodex Group OY | 2004-04-29 | Traditional | PDF ↗ |
| K040556 | TROPHYPAN C WITH ORTHOIMAGING/OMSIMAGING ACCESSORY | Eastman Kodak Company | 2004-04-07 | Special | PDF ↗ |
| K033690 | TROPHYPAN AND TROPHYPAN C | Trophy Radiologie | 2004-02-20 | Traditional | PDF ↗ |
| K033073 | ORTHOPHOS XG DS/CEPH | Sirona Dental Systems GmbH | 2003-10-10 | Special | PDF ↗ |
| K032355 | ORTHORALIX 9200 DDE, ORTHORALIX 9200 DDE PLUS CEPH, MODELS 5105 0161WW, 5105 0181WW | Dentsply Gendex | 2003-09-25 | Traditional | PDF ↗ |
| K031448 | RSV (RADIOLOGY SYSTEM VISIODENT | Visiodent SA | 2003-07-31 | Traditional | PDF ↗ |
| K031802 | CORIX 70 PLUS-USV | Coramex, S.A. | 2003-07-21 | Traditional | PDF ↗ |
| K030634 | ENDOS DC | Villa Sistemi Medicali S.P.A. | 2003-07-21 | Abbreviated | PDF ↗ |
| K031118 | INTRAOS 70 | Blue X Imaging Srl | 2003-07-08 | Traditional | PDF ↗ |
| K024285 | A/T X-RAY 70 | Air Techniques, Inc. | 2003-04-16 | Traditional | PDF ↗ |
Product code EHD · Class II · Dental. Data: openFDA.