K210977 is an FDA 510(k) clearance for the E-Dent 1000. This device is classified as a Material, Tooth Shade, Resin (Class II - Special Controls, product code EBF).
Submitted by Envisiontec GmbH (Gladbeck, DE). The FDA issued a Cleared decision on May 25, 2021, 54 days after receiving the submission on April 1, 2021.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3690.
| 510(k) Number | K210977 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 01, 2021 |
| Decision Date | May 25, 2021 |
| Days to Decision | 54 days |
| Submission Type | Traditional |
| 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 |