X-Ray, Tomography, Computed, Dental
Regulation 892.1750
11510(k)s in 12 months (136 all time)
3recalls in 12 months (7 all time)
7recalls that name a 510(k)
Top companies in OAS
| Company | 510(k)s | Recalls |
|---|---|---|
| VATECH Co., Ltd. | 19 | 0 |
| Ray Co., Ltd. | 15 | 0 |
| Palodex Group OY | 8 | 1 |
| Prexion Corporation | 9 | 0 |
| Cefla S.C. | 7 | 0 |
| Osstem Implant Co., Ltd. | 3 | 3 |
| Trophy | 4 | 1 |
| Genoray Co., Ltd. | 4 | 0 |
| Dentium Co., Ltd (Ict Branch) | 3 | 0 |
| Dentsply Sirona | 3 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 5, 2025 | OSSTEM Implant Co., Ltd. Osstem Dental X-Ray System T2Plus. Product Model Numbers
T2-C-P and T2-CS-P. Open, Classified |
OAS | K233806 |
| Nov 5, 2025 | OSSTEM Implant Co., Ltd. Osstem Dental X-Ray System T2. Product Model Numbers
T2-C and T2-CS. Open, Classified |
OAS | K212303 |
| Nov 5, 2025 | OSSTEM Implant Co., Ltd. Osstem Dental X-Ray System T1. Product Model Numbers
T1-C and T1-CS. Open, Classified |
OAS | K183475 |
| Aug 12, 2024 | Palodex Group Oy Orthopantomograph OP300 dental computed tomography x-ray system.
The X-ray device produces conventional 2D X-ray images and Xray
projection images for the reconstruction of a 3D view. The device is o Open, Classified |
OAS | K163423 |
| May 27, 2023 | Trophy SAS CS9600isanextraoralsystemintendedtoproducetwo-dimensionalandthree-dimensionaldigitalX-rayimagesofthedento-maxilofacial,ENT(Ear,NoseandThroat),cervicalspineandwristregionsatthedirectionofhealthcareprof Open, Classified |
OAS | K181136 K200183 |
| Dec 31, 2018 | KaVo Dental Technologies LLC cone-beam CT system Open, Classified |
OAS | K170813 K180947 |
| Nov 6, 2015 | Villa Radiology Systems LLC Owandy Radiology I -MAX Touch 3D X-ray Terminated |
OAS | K130443 |
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