# K992292: Gluma Comfort Bond + Desensitizer

- Pathway: 510(k) (Traditional)
- Applicant: Heraeus Kulzer, Inc.
- Decided: Oct 1, 1999 after 86 days
- Product code: KLE (Agent, Tooth Bonding, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3200
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
41 later devices descend from it; 2 cite it directly.
0 of 42 devices 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) Bond -1: named in the summary without a submission number
- (no number) ALL Bond 2: named in the summary without a submission number
- (no number) 3M Single Bond Dental Adhesive: named in the summary without a submission number
- (no number) One Step Dental Adhesive: named in the summary without a submission number

## Most influential descendants
- K040857: Modification to Adper Prompt (2004), 39 descendants of its own
- K060684: Adper Prompt, Adper Prompt L-Pop (2006), 38 descendants of its own
- K071131: UNO (2007), 35 descendants of its own
- K110302: Adhesive Exl-759 (2011), 34 descendants of its own
- K112118: Dreambond (2011), 8 descendants of its own

## Recalls of this device
- Jul 9, 2007 · Not classified · Z-0035-2008: The material may solidify in the bottle, and thus be rendered unusable.
- Jul 9, 2007 · Not classified · Z-0036-2008: The material may solidify in the bottle, and thus be rendered unusable.

## Indications for use
Gluma Comfort Bond + Desensitizer is a light curing single component enamel/dentin adhesive for bonding of all current brands of resin composite restorative materials and compomers. It also provides adhesion to metals such as amalgam. Gluma Comfort Bond + Desensitizer combines primer and adhesive in a single bottle. Serves as a desensitizer/preventative in dentin hypersensitivity conditions by means of sealing exposed dentinal tubules which effectively blocks the fluid flow in the tubules that cause sensitivity.

Source page: https://510kreport.com/device/K992292
Methodology: https://510kreport.com/methodology