K210115 is an FDA 510(k) clearance for the FiteBac CC OrthoSeal. This device is classified as a Adhesive, Bracket And Tooth Conditioner, Resin (Class II - Special Controls, product code DYH).
Submitted by Largent Health, LLC (Marietta, US). The FDA issued a Cleared decision on July 29, 2021, 191 days after receiving the submission on January 19, 2021.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3750.
| 510(k) Number | K210115 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 19, 2021 |
| Decision Date | July 29, 2021 |
| Days to Decision | 191 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 |