K770684 is an FDA 510(k) clearance for the CROWN, ACRYLIC, CORAL BRAND, PREFORMED. This device is classified as a Crown, Preformed (Class I - General Controls, product code ELZ).
Submitted by Parker Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 26, 1977, 14 days after receiving the submission on April 12, 1977.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3330.
| 510(k) Number | K770684 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 12, 1977 |
| Decision Date | April 26, 1977 |
| Days to Decision | 14 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | ELZ — Crown, Preformed |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.3330 |