The following data is part of a premarket notification filed by Vatech Co., Ltd with the FDA for Dental Computed Tomography X-ray System, Green X.
| Device ID | K201627 |
| 510k Number | K201627 |
| Device Name: | Dental Computed Tomography X-Ray System, Green X |
| Classification | X-ray, Tomography, Computed, Dental |
| Applicant | Vatech Co., Ltd 13, Samsung 1-ro 2-gil Hwaseong-si, KR 18449 |
| Contact | Daniel Kim |
| Correspondent | Dave Kim Mtech Group 7707 Fannin St. Ste 200 Houston, TX 77054 |
| Product Code | OAS |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-16 |
| Decision Date | 2020-10-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800016400717 | K201627 | 000 |
| 08800016400700 | K201627 | 000 |