# K131376: Smartcoat 2.5% Naf Varnish

- Pathway: 510(k) (Traditional)
- Applicant: Elevate Oral Care
- Decided: Aug 27, 2013 after 105 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 K945794 (1995). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092141: Vanish Varnish, 5% Sodium Fluoride White Varnish, 3M Espe Dental Products (2010) Summary page 1.
- K030922: Vivasens, Ivoclar Vivadent, Inc. (2003) Summary page 1.
- K945794: Duraphat, Inpharma (1995) Summary page 1.

## Most influential descendants
- K250714: FluoroDose Varnish (2025), 0 descendants of its own

## Indications for use
SmartCoat 2.5% NaF Varnish is intended for use on sensitive teeth, over exposed dentin and root surface sensitivity, and under temporary restorations or cements where post operative sensitivity is of concern. Rapid Desensitizer Provides rapid relief from sensitive teeth due to hypersensitivty

Source page: https://510kreport.com/device/K131376
Methodology: https://510kreport.com/methodology