K913582 is an FDA 510(k) clearance for the COMPATIT R. This device is classified as a Denture, Plastic, Teeth (Class II - Special Controls, product code ELM).
Submitted by Wilde-USA, Inc. (Chicago, US). The FDA issued a Cleared decision on June 24, 1993, 682 days after receiving the submission on August 12, 1991.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3590.
| 510(k) Number | K913582 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 12, 1991 |
| Decision Date | June 24, 1993 |
| Days to Decision | 682 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | ELM — Denture, Plastic, Teeth |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3590 |