K121980 is an FDA 510(k) clearance for the ZIRPRIME. This device is classified as a Powder, Porcelain (Class II - Special Controls, product code EIH).
Submitted by Kuraray Noritake Dental, Inc. (Washington, US). The FDA issued a Cleared decision on October 19, 2012, 105 days after receiving the submission on July 6, 2012.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6660.
| 510(k) Number | K121980 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 06, 2012 |
| Decision Date | October 19, 2012 |
| Days to Decision | 105 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | EIH — Powder, Porcelain |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.6660 |