# K073117: Dentin Desensitizer Agent

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Intl., Inc.
- Decided: Dec 19, 2007 after 44 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 K962812 (1996). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962812: Gluma Desensitizer/Gluma 3 Primer, Heraeus Kulzer, Inc. (1996) Summary page 1.
- K010957: Quell Desensitizer, Jeneric/Pentron, Inc. (2001) Summary page 1.

## Indications for use
Treating and preventing dentinal hypersensitivity. Can be used under direct restorations, under indirect restorations, and on cervical sensitivity.

Source page: https://510kreport.com/device/K073117
Methodology: https://510kreport.com/methodology