# K974390: Gluma One Bond

- Pathway: 510(k) (Traditional)
- Applicant: Heraeus Kulzer, Inc.
- Decided: Feb 4, 1998 after 75 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.
65 later devices descend from it; 1 cites it directly.
0 of 66 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 no predicate by number.

## Most influential descendants
- K990040: Clearfil SE Bond (1999), 64 descendants of its own
- K012442: Modification to Clearfil SE Bond (2001), 60 descendants of its own
- K032455: Panavia F 2.0 (2003), 34 descendants of its own
- K094007: Unicem (2010), 22 descendants of its own
- K100756: MALTA (2010), 19 descendants of its own

## Indications for use
GLUMA ONE BOND is a light curing single component enamel/dentin adhesive for bonding of all current brands of resin composite restorative materials and compomers. It also enhances adhesion to metals such as amalgam. GLUMA ONE BOND combines primer and adhesive in single bottle.

Source page: https://510kreport.com/device/K974390
Methodology: https://510kreport.com/methodology