The following data is part of a premarket notification filed by Largent Health, Llc with the FDA for Fitebac Cc Orthoseal.
| Device ID | K210115 |
| 510k Number | K210115 |
| Device Name: | FiteBac CC OrthoSeal |
| Classification | Adhesive, Bracket And Tooth Conditioner, Resin |
| Applicant | Largent Health, LLC 3698 Largent Way NW, Suite 101 Marietta, GA 30064 |
| Contact | Kirk Kimmerling |
| Correspondent | Elizabeth O’keeffe Secure BioMed Evaluations 7828 Hickory Flat Highway Suite 120 Woodstock, GA 30188 |
| Product Code | DYH |
| CFR Regulation Number | 872.3750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-19 |
| Decision Date | 2021-07-29 |