K992649 is an FDA 510(k) clearance for the ATD AUTOMATIC BRIDGE REMOVER. This device is classified as a Remover, Crown (Class I - General Controls, product code EIS).
Submitted by J. Morita USA, Inc. (Washington, US). The FDA issued a Cleared decision on October 29, 1999, 84 days after receiving the submission on August 6, 1999.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4565.
| 510(k) Number | K992649 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 06, 1999 |
| Decision Date | October 29, 1999 |
| Days to Decision | 84 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 |