K201795 is an FDA 510(k) clearance for the Transcend. This device is classified as a Material, Tooth Shade, Resin (Class II - Special Controls, product code EBF).
Submitted by Ultradent Product, Inc. (South Jordan, US). The FDA issued a Cleared decision on September 28, 2020, 90 days after receiving the submission on June 30, 2020.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3690.
| 510(k) Number | K201795 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 30, 2020 |
| Decision Date | September 28, 2020 |
| Days to Decision | 90 days |
| Submission Type | Abbreviated |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EBF — Material, Tooth Shade, Resin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3690 |