K220097 is an FDA 510(k) clearance for the PRESIDENT The Original. This device is classified as a Material, Impression (Class II - Special Controls, product code ELW).
Submitted by Colt?ne/Whaledent AG (Altstätten, CH). The FDA issued a Cleared decision on January 13, 2022, 1 day after receiving the submission on January 12, 2022.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3660.
| 510(k) Number | K220097 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 12, 2022 |
| Decision Date | January 13, 2022 |
| Days to Decision | 1 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | ELW - Material, Impression |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3660 |