# K983751: Quadrant Unichem

- Pathway: 510(k) (Traditional)
- Applicant: Cavex Holland BV
- Decided: Nov 30, 1998 after 38 days
- Product code: EBF (Material, Tooth Shade, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3690
- 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 UniChem is a two component, self-curing curing dental composite filling material, including an etching agent (Quadrant Total Etch) and a two component, self-curing enamel bonding agent, used in the adhesive restorative technique for the restoration of decayed teeth. Cauvity preparation is performed according to the principles of adhesive dentistry, adopting the minimal invasive technique for maximal preservation of sound tooth tissue. Quadrant UniChem is a composite for universal use: the restoration of both anterior and posterior teeth. It can also be used for core build-up: the reconstruction of a tooth with insufficient material left as a result of decay, before crown preparation.

Source page: https://510kreport.com/device/K983751
Methodology: https://510kreport.com/methodology