# K233768: Papacarie Duo

- Pathway: 510(k) (Traditional)
- Applicant: Elevate Oral Care
- Decided: Jul 18, 2024 after 237 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). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 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 5.
- K120620: Clean and Boost, Apex Dental Materials, Inc. (2012) Summary page 5.

## Indications for use
Papacarie Duo is a gel cleanser intended to clean the interior of a prepared cavity of a tooth prior to self-etch bonding procedures.

Source page: https://510kreport.com/device/K233768
Methodology: https://510kreport.com/methodology