K193553 is an FDA 510(k) clearance for the VarseoSmile Temp. This device is classified as a Crown And Bridge, Temporary, Resin (Class II - Special Controls, product code EBG).
Submitted by Bego Bremer Goldschlagerei Wilh. Herbst GmbH & Co. KG (Bremen, DE). The FDA issued a Cleared decision on May 18, 2020, 150 days after receiving the submission on December 20, 2019.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3770.
| 510(k) Number | K193553 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 20, 2019 |
| Decision Date | May 18, 2020 |
| Days to Decision | 150 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | EBG - Crown And Bridge, Temporary, Resin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3770 |