K771527 is an FDA 510(k) clearance for the ACCU. CROWN COLD CURE. This device is classified as a Crown And Bridge, Temporary, Resin (Class II - Special Controls, product code EBG).
Submitted by Parker Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 16, 1977, 8 days after receiving the submission on August 8, 1977.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3770.
| 510(k) Number | K771527 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 08, 1977 |
| Decision Date | August 16, 1977 |
| Days to Decision | 8 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | EBG — Crown And Bridge, Temporary, Resin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3770 |