# K190271: FiteBac Cavity Cleanser

- Pathway: 510(k) (Traditional)
- Applicant: Largent Health, LLC
- Decided: Jan 23, 2020 after 349 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: 1 generation back to K915668 (1992). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K915668: Bisco Cavity Cleanser, Bisco, Inc. (1992) Summary page 4.

## Most influential descendants
- K233768: Papacarie Duo (2024), 0 descendants of its own
- K200614: FiteBac Antimicrobial Cavity Cleanser (2020), 0 descendants of its own

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

Source page: https://510kreport.com/device/K190271
Methodology: https://510kreport.com/methodology