K020481 is an FDA 510(k) clearance for the PULPDENT POST CEMENT. This device is classified as a Cement, Dental (Class II - Special Controls, product code EMA).
Submitted by Pulpdent Corporation (Watertown, US). The FDA issued a Cleared decision on April 17, 2002, 63 days after receiving the submission on February 13, 2002.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3275.
| 510(k) Number | K020481 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 13, 2002 |
| Decision Date | April 17, 2002 |
| Days to Decision | 63 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 |