K172169 is an FDA 510(k) clearance for the Pulpdent (Activa) Pit and Fissure Sealant with MCP. This device is classified as a Sealant, Pit And Fissure, And Conditioner (Class II - Special Controls, product code EBC).
Submitted by Pulpdent Corporation (Watertown, US). The FDA issued a Cleared decision on January 5, 2018, 171 days after receiving the submission on July 18, 2017.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3765.
| 510(k) Number | K172169 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 18, 2017 |
| Decision Date | January 05, 2018 |
| Days to Decision | 171 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EBC — Sealant, Pit And Fissure, And Conditioner |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3765 |