K982458 is an FDA 510(k) clearance for the VIVALLOY HR. This device is classified as a Alloy, Amalgam (Class II - Special Controls, product code EJJ).
Submitted by Ab Ardent (Tonawanda, US). The FDA issued a Cleared decision on August 24, 1998, 40 days after receiving the submission on July 15, 1998.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3070.
| 510(k) Number | K982458 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 15, 1998 |
| Decision Date | August 24, 1998 |
| Days to Decision | 40 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | EJJ — Alloy, Amalgam |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3070 |