K190571 is an FDA 510(k) clearance for the StoneBite and StoneBite scan. This device is classified as a Material, Impression (Class II - Special Controls, product code ELW).
Submitted by Dreve Dentamid GmbH (Unna, DE). The FDA issued a Cleared decision on November 7, 2019, 246 days after receiving the submission on March 6, 2019.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3660.
| 510(k) Number | K190571 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 06, 2019 |
| Decision Date | November 07, 2019 |
| Days to Decision | 246 days |
| Submission Type | Abbreviated |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | ELW - Material, Impression |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3660 |