# K093575: Gluma Desensitizer Power Gel

- Pathway: 510(k) (Traditional)
- Applicant: Heraeus Kulzer, LLC
- Decided: Mar 5, 2010 after 107 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). 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)
- K962812: Gluma Desensitizer/Gluma 3 Primer, Heraeus Kulzer, Inc. (1996) Summary page 1.

## Indications for use
Reduction or even elimination of pain in exposed cervical areas that do not require restoration. Alleviation or reduction of dentine sensitivity after preparation of teeth to receive fixed prosthesis or restorations.

Source page: https://510kreport.com/device/K093575
Methodology: https://510kreport.com/methodology