# K112946: Activ Varnish

- Pathway: 510(k) (Traditional)
- Applicant: Pulpdent Corporation
- Decided: Dec 9, 2011 after 66 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 K051750 (2005). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093620: Pulpdent Fluoride Varnish, Pulpdent Corporation (2010) Summary page 1.
- K080249: Flor-Opal Varnish White; Models 4503, 4504, 4506, S4505, Ultradent Products, Inc. (2008) Summary page 1.
- K945794: Duraphat, Inpharma (1995) Summary page 1.
- K101104: Remin Pro, Voco GmbH (2010) Summary page 1.

## Cited in the summary but kept off the family tree
- K080741: Mega Soft Reusable Patient Return Electrode, Megadyne Medical Products, Inc. (2008). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K151302: Clinpro Varnish (2015), 0 descendants of its own

## Indications for use
Activ Varnish is a resin-based varnish, containing 17% Xylitol and less than 20% ethanol, that is applied to enamel or dentin for professional treatment of dental hypersensitivity. Activ Varnish treats hypersensitivity by releasing fluoride, calcium and phosphorus ions that precipitate on and, thereby, occlude dentinal tubules and fill superficial, non-carious enamel lesions.

Source page: https://510kreport.com/device/K112946
Methodology: https://510kreport.com/methodology