# K200614: FiteBac Antimicrobial Cavity Cleanser

- Pathway: 510(k) (Traditional)
- Applicant: Largent Health, LLC
- Decided: Jun 25, 2020 after 108 days
- Product code: LBH (Varnish, Cavity)
- Device class: 2
- Regulation: 21 CFR 872.3260
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K915668 (1992). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190271: FiteBac Cavity Cleanser, Largent Health, LLC (2020) Summary page 4.

## Indications for use
The FiteBac® Antimicrobial Cavity Cleanser with 2% K21 QAS is an antimicrobial aqueous ethanolic solution intended for cleansing and moistening/re-wetting of cavity preparations.

Source page: https://510kreport.com/device/K200614
Methodology: https://510kreport.com/methodology