K964692 is an FDA 510(k) clearance for the PERFECTIM. This device is classified as a Material, Impression (Class II - Special Controls, product code ELW).
Submitted by J. Morita USA, Inc. (Washington, US). The FDA issued a Cleared decision on February 25, 1997, 95 days after receiving the submission on November 22, 1996.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3660.
| 510(k) Number | K964692 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 22, 1996 |
| Decision Date | February 25, 1997 |
| Days to Decision | 95 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | ELW — Material, Impression |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3660 |