K022522 is an FDA 510(k) clearance for the PULPDENT PUTTY DAM. This device is classified as a Dam, Rubber (Class I - General Controls, product code EIE).
Submitted by Pulpdent Corporation (Watertown, US). The FDA issued a Cleared decision on September 26, 2002, 58 days after receiving the submission on July 30, 2002.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6300.
| 510(k) Number | K022522 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 30, 2002 |
| Decision Date | September 26, 2002 |
| Days to Decision | 58 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EIE — Dam, Rubber |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.6300 |