FDA Product Code
FDA Product Code MUH — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Dental
- 21 CFR Citation
- 872.1800
510(k) Clearances — 207 records · page 1 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261663 | EzSensor HD | Qpix Solutions, Inc. | 2026-09-30 | Traditional | PDF ↗ |
| K251793 | SOTA Cloud Smart Sensor (1.5) | Sota Cloud Corp. | 2026-03-03 | Traditional | PDF ↗ |
| K252570 | EzSensor HD, EzSensor UHD | Qpix Solutions, Inc. | 2025-11-10 | Special | PDF ↗ |
| K250687 | Cocoon Solo (DX-7020s) | Dexcowin Global, Inc. | 2025-10-24 | Traditional | PDF ↗ |
| K251206 | Digital X-Ray DentiMax Pro Imaging System | Dentimax, Inc. | 2025-09-24 | Traditional | PDF ↗ |
| 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) | VATECH Co., Ltd. | 2024-10-25 | Traditional | PDF ↗ |
| K242778 | X Sensor (Model: IOS-A15IF, HDI-15DGF) | Qpix Solutions, Inc. | 2024-10-11 | Special | PDF ↗ |
| K241649 | DUO1 and DUO2 | Zinnovi, Inc. | 2024-07-05 | Traditional | PDF ↗ |
| K232325 | RAYSCAN a-Expert | Ray Co., Ltd. | 2024-04-18 | Traditional | PDF ↗ |
| K231660 | Digital image scanner of dental | Jiangsu Dynamic Medical Technology Co., Ltd. | 2023-12-20 | Traditional | PDF ↗ |
| K233053 | DEXIS Ti2 Intraoral Sensor, DEXIS IXS Size 1 Intraoral Sensor, DEXIS IXS Size 2 Intraoral Sensor | Dental Imaging Technologies Corporation | 2023-11-21 | Traditional | PDF ↗ |
| K232552 | TuxDeluxe (Size 1 6100B, Size 2 6101B) | Tuxedo Imaging, LLC | 2023-10-20 | Abbreviated | PDF ↗ |
| K230998 | Digital Wireless Intraoral X-Ray Sensor | Iray Imaging Technology (Haining) Limited | 2023-10-20 | Special | PDF ↗ |
| K230916 | WeSensor | Picopack, Inc. | 2023-10-10 | Traditional | PDF ↗ |
| K232255 | EZSensor XHD | Qpix Solutions, Inc. | 2023-09-27 | Traditional | PDF ↗ |
| K232158 | GenX-CR | Genoray Co., Ltd. | 2023-09-13 | Traditional | PDF ↗ |
| K231202 | QuickRayPRO | Denterprise International, Inc. | 2023-06-22 | Traditional | PDF ↗ |
| K230811 | Digital Intraoral X-Ray Sensor | Iray Imaging Technology (Haining) Limited | 2023-04-21 | Special | PDF ↗ |
| K230732 | Eagle S/Saevo Slim/D700 Slim | Alliage S/A Industrias Medica Odontológico. | 2023-04-11 | Traditional | PDF ↗ |
| K230095 | ScanX Swift 2.0, ScanX Swift View 2.0 | Durr Dental SE | 2023-02-06 | Special | PDF ↗ |
| K221955 | Brasseler GEM, Brasseler GEM10, Brasseler GEM15, Brasseler GEM20 | Realcloud Imaging Inc. Dba Realcloud Imaging | 2022-08-31 | Traditional | PDF ↗ |
| K221008 | HDR Sensor- HDR361 (Size 1), HDR Sensor- HDR461 (Size 2) | Shanghai Handy Medical Equipment Co., Ltd. | 2022-06-22 | Traditional | PDF ↗ |
| K220423 | PAPAYA & PAPAYA Plus | Genoray Co., Ltd. | 2022-05-19 | Traditional | PDF ↗ |
| K220556 | OpenSensorX Series | Dentimax, Inc. | 2022-04-13 | Special | PDF ↗ |
| K220422 | Dental sensors NanoPix1, NanoPix2 | Iray Technology Taicang , Ltd. | 2022-03-11 | Special | PDF ↗ |
| K214091 | Dental Image Plate Scanner, Model DFC-4T-SMART | Hefei Dentafilm Medical Equipment Co., Ltd. | 2022-03-02 | Traditional | PDF ↗ |
| K220277 | Digital Intraoral X-ray Sensor | Shenzhen Xpectvision Technology Co., Ltd. | 2022-02-17 | Traditional | PDF ↗ |
| K213637 | JAZZ Solo sensor | Jazz Imaging, LLC Dba Jazz Imaging | 2021-12-10 | Special | PDF ↗ |
| K212279 | Digital Intraoral X-ray Imaging System | Iray Technology Taicang , Ltd. | 2021-10-07 | Traditional | PDF ↗ |
| K212080 | Imaging Plate Scanner, i-Scan | Guilin Woodpecker Medical Instrument Co., Ltd. | 2021-09-27 | Traditional | PDF ↗ |
| K202369 | RXS 1000 | Rolence Enterprise, Inc. | 2021-09-15 | Traditional | PDF ↗ |
| K212103 | StarX-1, StarX-2, StarX PRO-1 and StarX PRO-2 | Fona S.R.L | 2021-08-30 | Traditional | PDF ↗ |
| K211317 | CRUXVIEW | Cruxell Corp. | 2021-07-29 | Traditional | PDF ↗ |
| K211688 | DC-Air and Athlos-1 and Athlos-Air | Athlos OY | 2021-07-22 | Traditional | PDF ↗ |
| K210312 | PlutoX Digital Intraoral X-Ray Imaging System | Iray Technology Taicang , Ltd. | 2021-04-23 | Traditional | PDF ↗ |
| K203116 | SensorX | Durr Dental SE | 2021-03-19 | Traditional | PDF ↗ |
| K203374 | X-MIND prime (under trade mark Acteon), I-MAX (under trade mark Owandy Radiology) | De Götzen S.R.L. | 2021-02-05 | Abbreviated | PDF ↗ |
| K202664 | Clio Prime and Clio Pedo | Sota Precision Optics, Inc. Dba Sota Imaging | 2020-11-06 | Traditional | PDF ↗ |
| K202633 | ScanX Edge | Dürr Dental SE | 2020-10-07 | Special | PDF ↗ |
| K200625 | I-View Gold and Imagen Gold Dental Sensors | Trident S.R.L | 2020-04-15 | Traditional | PDF ↗ |
| K200284 | R-Sensor, R-Sensor | Remedi Co., Ltd. | 2020-02-28 | Traditional | PDF ↗ |
| K191719 | X-MIND Trium | De Gotzen S.R.L. | 2020-02-20 | Traditional | PDF ↗ |
| K192766 | Digital Intraoral Imaging Plate System | Fsusen Technology Co., Ltd. | 2019-12-05 | Traditional | PDF ↗ |
| K191623 | ScanX Touch/ScanX Duo Touch | Air Techniques, Inc. | 2019-08-21 | Traditional | PDF ↗ |
| K190234 | ODI HD Dental Sensor | Cnd Global Technologies, Inc. | 2019-03-01 | Traditional | PDF ↗ |
| K183637 | Cruxcan (CRX-1000) | Cruxell Corp. | 2019-02-12 | Traditional | PDF ↗ |
| K182198 | Panoura X-ERA PF/NF/MF | The Yoshida Dental Mfg. Co., Ltd. | 2019-01-31 | Traditional | PDF ↗ |
| K181297 | DENTIOIII series (DENTIOIII, DENTIOIII-S) | Hdx Will Corp. | 2018-11-21 | Traditional | PDF ↗ |
| K181636 | Aurora | Sodium Systems, LLC | 2018-07-20 | Traditional | PDF ↗ |
| K181358 | Televere Digital Dental Imaging System | Televere Systems, Inc. | 2018-06-20 | Traditional | PDF ↗ |
| K173646 | FS Ergo | Palodex Group OY | 2017-12-19 | Traditional | PDF ↗ |
| K172918 | DEXIS Titanium, KaVo IXS HD (Size 1, Size 2) | Kavo Dental Technologies, LLC | 2017-12-18 | Traditional | PDF ↗ |
| K173046 | Cocoon Portable Handheld X-Ray System | Dexcowin Co., Ltd. | 2017-10-26 | Special | PDF ↗ |
| K162190 | Rotograph Prime (under trade mark Villa Sistemi Medicali), I-MAX (under trade mark Owandy Radiology) | Villa Sistemi Medicali S.P.A. | 2017-07-06 | Abbreviated | PDF ↗ |
| K170733 | ScanX Intraoral View | Duerr Dental AG | 2017-05-01 | Traditional | PDF ↗ |
| K170731 | System, X-Ray, Extra oral Source, Digital, PaX-i Plus, PaX-i Insight | VATECH Co., Ltd. | 2017-04-04 | Traditional | PDF ↗ |
| K163175 | Bel-Cypher Pro | Takara Belmont Corporation | 2017-03-20 | Traditional | PDF ↗ |
| K163224 | JAZZ SOLO Sensor | Jazz Imaging, LLC | 2017-03-09 | Traditional | PDF ↗ |
| K163282 | Apex Dental Sensors | Masterlink, LLC | 2017-02-28 | Traditional | PDF ↗ |
| K162585 | SuniIQ Digital Radiography System | Suni Medical Imaging, Inc. | 2016-11-04 | Traditional | PDF ↗ |
| K162619 | I View and Imagen Sensor | Trident S.R.L | 2016-11-04 | Traditional | PDF ↗ |
| K161131 | FONA Pan/Ceph | Fona S.R.L | 2016-11-03 | Traditional | PDF ↗ |
| K160788 | RIOScan (RPS500) | Ray Co., Ltd. | 2016-04-15 | Traditional | PDF ↗ |
| K160386 | ReadeR, VieweR, QuickScan PSP | Trident S.R.L | 2016-03-10 | Traditional | PDF ↗ |
| K153144 | TIO-H DIGITAL RADIOGRAPHY SENSOR | Denttio, Inc. | 2016-02-10 | Traditional | PDF ↗ |
| K152162 | Myray- HYPERION X5 | Cefla S.C. | 2015-12-24 | Traditional | PDF ↗ |
| K151926 | QuickRay HD Intraoral Sensor | Denterprise International, Inc. | 2015-12-14 | Traditional | PDF ↗ |
| K153060 | Digital Dental Intra Oral Sensor, EzSensor Classic, EzSensor HD, HDI-P, HDI-S | Rayence Co., Ltd. | 2015-11-10 | Special | PDF ↗ |
| K150823 | EDLENi Intra-Oral Sensor | Edlen Imaging, LLC | 2015-08-26 | Abbreviated | PDF ↗ |
| K151087 | CS 8100SC, CS8100SC Access | Trophy | 2015-08-21 | Traditional | PDF ↗ |
| K142995 | SOPIX | Sopro - Acteon Group | 2015-08-17 | Traditional | PDF ↗ |
| 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 | Sopro - Acteon Group | 2015-07-31 | Traditional | PDF ↗ |
| K151707 | EzSensor Soft, EzSensor Soft i, EzSensor Bio, and EzSensor Bio i | Rayence Co., Ltd. | 2015-07-19 | Special | PDF ↗ |
| K150797 | Digital Dental Intra Oral Sensor, EzSensor Smart | Rayence Co., Ltd. | 2015-05-01 | Special | PDF ↗ |
| K142058 | RAYSCAN A-EXPERT | Ray Co., Ltd. | 2015-04-22 | Traditional | PDF ↗ |
| K143703 | NICAL SMART MICRO CR system for intraoral dental images | Nical Spa | 2015-03-18 | Traditional | PDF ↗ |
| K143753 | Digital Dental Intra Oral Sensor, EzSensor Soft, EzSensor Bio | Rayence Co., Ltd. | 2015-03-10 | Special | PDF ↗ |
| K141700 | PAPAYA PLUS, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM | Genoray Co., Ltd. | 2014-10-31 | Traditional | PDF ↗ |
| K140013 | SOPIX INSIDE, SOPIX2 INSIDE | Sopro - Acteon Group | 2014-09-05 | Traditional | PDF ↗ |
| K141130 | ENCOMPASS | Panoramic Corp. | 2014-07-30 | Traditional | PDF ↗ |
| K133206 | Z-RAY INTRA-ORAL DIGITAL RADIOGRAPHY SYSTEM | Zuma Dental, LLC | 2014-05-13 | Traditional | PDF ↗ |
| K134055 | ADX4000W | Dexcowin Co., Ltd. | 2014-05-09 | Special | PDF ↗ |
| K133271 | OPTEO, VIDEOGRAPH HD | Owandy | 2014-04-28 | Special | PDF ↗ |
| K133007 | DX3000-L | Dexcowin Co., Ltd. | 2014-04-24 | Special | PDF ↗ |
| K133231 | DIGORA OPTIME | Instrumentarium Dental, Palodex Group OY | 2014-03-20 | Special | PDF ↗ |
| K130419 | PAPAYA PLUS, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM | Genoray Co., Ltd. | 2013-11-06 | Traditional | PDF ↗ |
| K131693 | RAYSCAN A-EXPERT | Ray Co., Ltd. | 2013-11-01 | Special | PDF ↗ |
| K131442 | FIRECR DENTALIMAGING SYSTEM | 3Disc Americas | 2013-09-06 | Traditional | PDF ↗ |
| K130088 | PORT VIEW, DIGITAL X-RAY SENSOR SYSTEM | Genoray Co., Ltd. | 2013-07-18 | Traditional | PDF ↗ |
| K130585 | PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM, PAX-I DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM | VATECH Co., Ltd. | 2013-07-15 | Traditional | PDF ↗ |
| K122918 | RAYSCAN A-EXPERT | Ray Co., Ltd. | 2013-03-15 | Traditional | PDF ↗ |
| K122806 | IMAGE WORKS PANOURA | Mic International | 2013-03-08 | Traditional | PDF ↗ |
| K121800 | POINT 500 HD POINT500C HD | Pointnix Co., Ltd. | 2013-01-24 | Traditional | PDF ↗ |
| K122643 | VANTAGE MODEL V5000, V5100, V5000C, V5100C | Midmark Corp. | 2013-01-07 | Traditional | PDF ↗ |
| K123419 | EVA SELECT DIGITAL DENTAL IMAGING SYSTEM | Afp Imaging Corp. | 2012-12-27 | Special | PDF ↗ |
| K122155 | PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM PAX-I DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM | VATECH Co., Ltd. | 2012-09-04 | Special | PDF ↗ |
| K120263 | VOLUX 21C, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM | Genoray Co., Ltd. | 2012-07-10 | Traditional | PDF ↗ |
| K120975 | CS 8100 CS 8100 ACCESS | Trophy | 2012-06-22 | Traditional | PDF ↗ |
| K120106 | APIXIA DIGIREX DIGITAL DENTAL REDIOGRAPHY SYSTEM | Apixia, Inc. | 2012-05-07 | Traditional | PDF ↗ |
| K113672 | PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM | VATECH Co., Ltd. | 2012-03-27 | Traditional | PDF ↗ |
Product code MUH · Class II · Dental. Data: openFDA.