# K113146: PCXX Varnish

- Pathway: 510(k) (Abbreviated)
- Applicant: Ross Healthcare, Inc.
- Decided: Jan 23, 2012 after 91 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 K945794 (1995). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961893: Duraflor, Pharmascience, Inc. (1996) Summary page 1.
- K945794: Duraphat, Inpharma (1995) Summary page 1.
- K030488: Fluorilaq, Pascal Co., Inc. (2003) Summary page 1.

## Indications for use
Treatment of hypersensitive teeth Use on exposed dentin and root sensitivity Under temporary restoratives and cements where post-operative sensitivity is of concern.

Source page: https://510kreport.com/device/K113146
Methodology: https://510kreport.com/methodology