K962383 is an FDA 510(k) clearance for the PULPDENT RESILUTE II. 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 September 3, 1996, 75 days after receiving the submission on June 20, 1996.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3275.
| 510(k) Number | K962383 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 20, 1996 |
| Decision Date | September 03, 1996 |
| Days to Decision | 75 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 |