K190998 is an FDA 510(k) clearance for the BA Pit & Fissure Sealant. This device is classified as a Sealant, Pit And Fissure, And Conditioner (Class II - Special Controls, product code EBC).
Submitted by Apex Dental Materials, Inc. (Lake Zurich, US). The FDA issued a Cleared decision on November 8, 2019, 206 days after receiving the submission on April 16, 2019.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3765.
| 510(k) Number | K190998 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 16, 2019 |
| Decision Date | November 08, 2019 |
| Days to Decision | 206 days |
| Submission Type | Abbreviated |
| 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 |