K955017 is an FDA 510(k) clearance for the PULPDENT RESILUTE. This device is classified as a Cement, Dental (Class II - Special Controls, product code EMA).
Submitted by Pulpdent Corp. (Watertown, US). The FDA issued a Cleared decision on December 1, 1995, 29 days after receiving the submission on November 2, 1995.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3275.
| 510(k) Number | K955017 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 02, 1995 |
| Decision Date | December 01, 1995 |
| Days to Decision | 29 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EMA — Cement, Dental |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3275 |