# K962812: Gluma Desensitizer/Gluma 3 Primer

- Pathway: 510(k) (Traditional)
- Applicant: Heraeus Kulzer, Inc.
- Decided: Oct 7, 1996 after 81 days
- Product code: KLE (Agent, Tooth Bonding, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 3 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K222357: DenMat Glutaraldehyde Desensitizer (2022), 0 descendants of its own
- K093575: Gluma Desensitizer Power Gel (2010), 0 descendants of its own
- K073117: Dentin Desensitizer Agent (2007), 0 descendants of its own

Source page: https://510kreport.com/device/K962812
Methodology: https://510kreport.com/methodology