K030435 is an FDA 510(k) clearance for the BIOUNIVERSAL PKF. This device is classified as a Alloy, Gold-based Noble Metal (Class II - Special Controls, product code EJT).
Submitted by Ivoclar Vivadent, Inc. (Amherst, US). The FDA issued a Cleared decision on April 15, 2003, 64 days after receiving the submission on February 10, 2003.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3060.
| 510(k) Number | K030435 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 10, 2003 |
| Decision Date | April 15, 2003 |
| Days to Decision | 64 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | EJT — Alloy, Gold-based Noble Metal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3060 |