K780528 is an FDA 510(k) clearance for the PREMIER CARVERS, STYLE #21C & 21D. This device is classified as a Carver, Dental Amalgam, Operative (Class I - General Controls, product code EKH).
Submitted by Premier Dental Products Co. (Mchenry, US). The FDA issued a Cleared decision on April 19, 1978, 16 days after receiving the submission on April 3, 1978.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4565.
| 510(k) Number | K780528 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 03, 1978 |
| Decision Date | April 19, 1978 |
| Days to Decision | 16 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | EKH — Carver, Dental Amalgam, Operative |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4565 |