K854795 is an FDA 510(k) clearance for the HAZELTON TEMPORARY CROWN AND BRIDGE REMOVER. This device is classified as a Remover, Crown (Class I - General Controls, product code EIS).
Submitted by Fran Hazelton Co. (Orland, US). The FDA issued a Cleared decision on March 4, 1986, 92 days after receiving the submission on December 2, 1985.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4565.
| 510(k) Number | K854795 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 02, 1985 |
| Decision Date | March 04, 1986 |
| Days to Decision | 92 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | EIS — Remover, Crown |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4565 |