# K984042: Quadrant Core LC

- Pathway: 510(k) (Traditional)
- Applicant: Cavex Holland BV
- Decided: Dec 4, 1998 after 21 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 Core LC is a light curing dental composite filling material used in the adhesive restorative technique. Cavity preparation is performed according to the principles of adhesive dentistry, adopting the minimal invasive technique for maximal preservation of sound tooth tissue. Quadrant Core LC is especially designed 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/K984042
Methodology: https://510kreport.com/methodology