K211101 is an FDA 510(k) clearance for the E-Temp. This device is classified as a Crown And Bridge, Temporary, Resin (Class II - Special Controls, product code EBG).
Submitted by Envisiontec GmbH (Gladbeck, DE). The FDA issued a Cleared decision on June 14, 2021, 62 days after receiving the submission on April 13, 2021.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3770.
| 510(k) Number | K211101 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 13, 2021 |
| Decision Date | June 14, 2021 |
| Days to Decision | 62 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EBG - Crown And Bridge, Temporary, Resin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3770 |