K113818 is an FDA 510(k) clearance for the EMBRACE WETBOND PIT AND FISSURE SEALANT, LOW FILL. 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 March 21, 2012, 85 days after receiving the submission on December 27, 2011.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3765.
| 510(k) Number | K113818 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 27, 2011 |
| Decision Date | March 21, 2012 |
| Days to Decision | 85 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 |