# K983545: Quadrant Unibond

- Pathway: 510(k) (Traditional)
- Applicant: Cavex Holland BV
- Decided: Nov 18, 1998 after 40 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Quadrant UniBond is used in the adhesive restorative technique for bonding of dental composite restorations to tooth tissue and for sealing of exposed root surfaces. Quadrant UniBond is used in the so-called “total etch technique”, in combination with an etching agent such as Quadrant Total Etch. Conditioning of the enamel and dentin with this technique will enable the bonding agent to penetrate and seal off the cavity wall, thus forming an adhesive layer for the composite filling material.

Source page: https://510kreport.com/device/K983545
Methodology: https://510kreport.com/methodology