K183304 is an FDA 510(k) clearance for the Prettau, ICE, Z-White zirconia blanks. 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 April 4, 2019, 127 days after receiving the submission on November 28, 2018.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6660.
| 510(k) Number | K183304 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 28, 2018 |
| Decision Date | April 04, 2019 |
| Days to Decision | 127 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 |