K902392 is an FDA 510(k) clearance for the COLTOSOL TEMPORARY ENDODONTIC FILLING MATERIAL. This device is classified as a Cement, Dental (Class II - Special Controls, product code EMA).
Submitted by Coltene, Inc. (Chicago, US). The FDA issued a Cleared decision on August 28, 1990, 90 days after receiving the submission on May 30, 1990.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3275.
| 510(k) Number | K902392 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 30, 1990 |
| Decision Date | August 28, 1990 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | EMA — Cement, Dental |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3275 |