K132230 is an FDA 510(k) clearance for the ICE ZIRKON TRANSLUZENT. This device is classified as a Powder, Porcelain (Class II - Special Controls, product code EIH).
Submitted by Zirkonzahn Srl (Silver Creek, US). The FDA issued a Cleared decision on November 5, 2014, 475 days after receiving the submission on July 18, 2013.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6660.
| 510(k) Number | K132230 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 18, 2013 |
| Decision Date | November 05, 2014 |
| Days to Decision | 475 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 |