K951299 is an FDA 510(k) clearance for the EASY PNEUMATIC CROWN AND BRIDGE REMOVER. This device is classified as a Remover, Crown (Class I - General Controls, product code EIS).
Submitted by Dentco, Inc. (White Plains, US). The FDA issued a Cleared decision on August 29, 1995, 160 days after receiving the submission on March 22, 1995.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4565.
| 510(k) Number | K951299 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 22, 1995 |
| Decision Date | August 29, 1995 |
| Days to Decision | 160 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | EIS — Remover, Crown |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4565 |