K121359 is an FDA 510(k) clearance for the IPS 99 ONE AND IPS 99 CERAM. This device is classified as a Powder, Porcelain (Class II - Special Controls, product code EIH).
Submitted by Ivoclar Vivadent, AG (Amherst, US). The FDA issued a Cleared decision on July 27, 2012, 81 days after receiving the submission on May 7, 2012.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6660.
| 510(k) Number | K121359 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 07, 2012 |
| Decision Date | July 27, 2012 |
| Days to Decision | 81 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 |