# K052263: Multiple (Tooth Desensitizer)

- Pathway: 510(k) (Traditional)
- Applicant: Cosmedent, Inc.
- Decided: Dec 16, 2005 after 119 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.
No later device cites it as a predicate yet.
0 of 1 device 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) Ultradent UltraEZ: named in the summary without a submission number

## Indications for use
The product is used either by a dental professional in the dental office or by a patient at home to treat dentin sensitivity.

Source page: https://510kreport.com/device/K052263
Methodology: https://510kreport.com/methodology