# K992985: Gluma Comfort Bond

- Pathway: 510(k) (Traditional)
- Applicant: Heraeus Kulzer, Inc.
- Decided: Oct 14, 1999 after 41 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; 1 cites 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. 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
- K043562: BC Plus (2005), 2 descendants of its own
- K192392: DiaPlus (2020), 1 descendant of its own
- K210421: Diafil & Diafil Capsule (2021), 0 descendants of its own

## Indications for use
GLUMA® Comfort Bond is a light curing single component bonding agent use in restorative adhesive dentistry specifically developed for bonding resin-based filling materials (e.g. composites, compomers, Polyglas®) to hard dental tissues. Other indications include bonding of amalgam and laboratory-produced restorations. GLUMA® Comfort Bond permits priming and bonding to be carried out in single step.

Source page: https://510kreport.com/device/K992985
Methodology: https://510kreport.com/methodology