K994435 is an FDA 510(k) clearance for the OPC 3G ALL-CERAMIC SYSTEM, CORE AND OVERLAY PORCELAINS. This device is classified as a Powder, Porcelain (Class II - Special Controls, product code EIH).
Submitted by Jeneric/Pentron, Inc. (Wallingford, US). The FDA issued a Cleared decision on February 10, 2000, 42 days after receiving the submission on December 30, 1999.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6660.
| 510(k) Number | K994435 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 30, 1999 |
| Decision Date | February 10, 2000 |
| Days to Decision | 42 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 |