# K092141: Vanish Varnish, 5% Sodium Fluoride White Varnish

- Pathway: 510(k) (Traditional)
- Applicant: 3M Espe Dental Products
- Decided: Mar 10, 2010 after 238 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
No predicates in its family tree.
8 later devices descend from it; 7 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) 3M™ ESPE™ Vanish™ Varnish: named in the summary without a submission number
- (no number) Enamel Pro® Varnish: named in the summary without a submission number

## Most influential descendants
- K131376: Smartcoat 2.5% Naf Varnish (2013), 1 descendant of its own
- K250714: FluoroDose Varnish (2025), 0 descendants of its own
- K230333: Profisil Fluoride Varnish Combi pack  (14801), Profisil Fluoride Varnish Normal pack mint (14802), Profisil Fluoride Varnish Normal pack berry (14804), Profisil Fluoride Varnish Normal pack unflavored (14806), Profisil Fluoride Varnish Sample pack (14800) (2023), 0 descendants of its own
- K231338: 3M™ Clinpro™ Clear 2.1% Sodium Fluoride Treatment (2023), 0 descendants of its own
- K182917: FluoroCal (2019), 0 descendants of its own

## 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/K092141
Methodology: https://510kreport.com/methodology