K850036 is an FDA 510(k) clearance for the COLTENE PRECISE. This device is classified as a Material, Impression (Class II - Special Controls, product code ELW).
Submitted by Coltene, Inc. (Chicago, US). The FDA issued a Cleared decision on February 8, 1985, 32 days after receiving the submission on January 7, 1985.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3660.
| 510(k) Number | K850036 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 07, 1985 |
| Decision Date | February 08, 1985 |
| Days to Decision | 32 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | ELW — Material, Impression |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3660 |