K811667 is an FDA 510(k) clearance for the COLTENE PRESSURE SPOT INDICATOR. This device is classified as a Material, Impression (Class II - Special Controls, product code ELW).
Submitted by Coltene, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 15, 1981, 30 days after receiving the submission on June 15, 1981.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3660.
| 510(k) Number | K811667 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 15, 1981 |
| Decision Date | July 15, 1981 |
| Days to Decision | 30 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 |