The following data is part of a premarket notification filed by Largent Health, Llc with the FDA for Fitebac Antimicrobial Cavity Cleanser.
| Device ID | K200614 |
| 510k Number | K200614 |
| Device Name: | FiteBac Antimicrobial Cavity Cleanser |
| Classification | Varnish, Cavity |
| Applicant | Largent Health, LLC 3698 Largent Way NW, Suite 101 Marietta, GA 30064 |
| Contact | Kirk Kimmerling |
| Correspondent | Elizabeth O’keeffe Secure BioMed Evalutations 7828 Hickory Flat Highway Suite 120 Woodstock, GA 30188 |
| Product Code | LBH |
| CFR Regulation Number | 872.3260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-09 |
| Decision Date | 2020-06-25 |