K162598 is an FDA 510(k) clearance for the HAPI Seal. This device is classified as a Sealant, Pit And Fissure, And Conditioner (Class II - Special Controls, product code EBC).
Submitted by Bisco, Inc. (Schaumburg, US). The FDA issued a Cleared decision on May 23, 2017, 246 days after receiving the submission on September 19, 2016.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3765.
| 510(k) Number | K162598 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 19, 2016 |
| Decision Date | May 23, 2017 |
| Days to Decision | 246 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 |