# K153334: Oral-B 5% Sodium Fluoride Varnish

- Pathway: 510(k) (Traditional)
- Applicant: Young Dental Manufacturing Co. 1, LLC
- Decided: May 20, 2016 after 183 days
- Product code: LBH (Varnish, Cavity)
- Device class: 2
- Regulation: 21 CFR 872.3260
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K040098 (2004). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040098: Varnishamerica, Medical Products Laboratories, Inc. (2004) Summary page 4.

## Most influential descendants
- K192381: DFV Desensitizing Varnish-Strawberry Flavor, DFV Desensitizing Varnish-Bubblegum (Tutti-Fruity) Flavor, DFV Desensitizing Varnish-Spearmint Flavor, DFV Desensitizing Varnish-Chocolate Flavor, DFV Desensitizing Varnish-Marshmallow Flavor (2020), 0 descendants of its own

## Recalls of this device
- May 23, 2023 · Class II · Z-1697-2023: The Iris 5% Fluoride Varnish White Mint package lot 207540 may contain units of 5% Fluoride Varnish Bubblegum.
- Oct 30, 2019 · Class II · Z-0661-2020: Product shelf life may be shorter than that indicated on the label.

## Indications for use
Oral-B 5% Sodium Fluoride Varnish is a fluoride-containing preparation for the treatment of dentinal hypersensitivity and for the reduction of post-operative sensitivity.

Source page: https://510kreport.com/device/K153334
Methodology: https://510kreport.com/methodology