K974202 is an FDA 510(k) clearance for the PULPDENT CAVITY CLEANSER, PULPDENT CAVITY CLEANSER PLUS. This device is classified as a Varnish, Cavity (Class II - Special Controls, product code LBH).
Submitted by Pulpdent Corp. (Watertown, US). The FDA issued a Cleared decision on March 19, 1998, 129 days after receiving the submission on November 10, 1997.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3260.
| 510(k) Number | K974202 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 10, 1997 |
| Decision Date | March 19, 1998 |
| Days to Decision | 129 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | LBH — Varnish, Cavity |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3260 |