K213722 is an FDA 510(k) clearance for the ICE Ceramics, ICE Stains, Fresco. This device is classified as a Powder, Porcelain (Class II - Special Controls, product code EIH).
Submitted by Zirkonzahn Srl (Gais, IT). The FDA issued a Cleared decision on December 14, 2022, 383 days after receiving the submission on November 26, 2021.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6660.
| 510(k) Number | K213722 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 26, 2021 |
| Decision Date | December 14, 2022 |
| Days to Decision | 383 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EIH - Powder, Porcelain |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.6660 |