K242537 is an FDA 510(k) clearance for the BracePaste Fluoride Sealant. This device is classified as a Adhesive, Bracket And Tooth Conditioner, Resin (Class II - Special Controls, product code DYH).
Submitted by American Orthodontics Corp. (Sheboygan, US). The FDA issued a Cleared decision on August 27, 2024, 1 day after receiving the submission on August 26, 2024.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3750.
| 510(k) Number | K242537 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 26, 2024 |
| Decision Date | August 27, 2024 |
| Days to Decision | 1 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | DYH — Adhesive, Bracket And Tooth Conditioner, Resin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3750 |