# K222891: Dental Desensitizer

- Pathway: 510(k) (Traditional)
- Applicant: Guangzhou Beogene Biotech Co., Ltd.
- Decided: May 25, 2023 after 244 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 K061438 (2007). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061438: Ultraez Desensitizing Gel, Ultradent Products, Inc. (2007) Summary page 4.

## Indications for use
The Dental Desensitizer is a colorless transparent gel that is applied to the sensitive part of the tooth to form a film, sealing the exposed dentin tubules and relieving dentin allergy. The product is used either by a dental professional in the dental office or provided to the patient for home treatment of dentin sensitivity.

Source page: https://510kreport.com/device/K222891
Methodology: https://510kreport.com/methodology