K213343 is an FDA 510(k) clearance for the Saremco Print CROWNTEC. This device is classified as a Material, Tooth Shade, Resin (Class II - Special Controls, product code EBF).
Submitted by Saremco Dental AG (Rebstein, CH). The FDA issued a Cleared decision on January 21, 2022, 106 days after receiving the submission on October 7, 2021.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3690.
| 510(k) Number | K213343 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 07, 2021 |
| Decision Date | January 21, 2022 |
| Days to Decision | 106 days |
| Submission Type | Abbreviated |
| 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 |