# K042806: Quadrant Unit-1-Bond

- Pathway: 510(k) (Traditional)
- Applicant: Cavex Holland BV
- Decided: Nov 24, 2004 after 43 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 Uni-1-Bond is a light curing, single component bonding agent for universal use in combination with adhesive restorations. Quadrant Uni-l-Bond primes and bonds in one step. Quadrant Uni-l-Bond is an ethanol-based formulation of light-activated, adhesive resins.

Source page: https://510kreport.com/device/K042806
Methodology: https://510kreport.com/methodology