# K983549: Quadrant Anterior Shine

- Pathway: 510(k) (Traditional)
- Applicant: Cavex Holland BV
- Decided: Nov 23, 1998 after 45 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 Anterior Shine is a light curing dental composite filling material used in the adhesive restorative technique for the restoration of decayed teeth. Cavity preparation is performed according to the principles of adhesive dentistry, adopting the minimal invasive technique for maximal preservation of sound tooth tissue. Quadrant Anterior Shine is especially designed for the restoration of anterior teeth: a composite for aesthetic and cosmetic dentistry.

Source page: https://510kreport.com/device/K983549
Methodology: https://510kreport.com/methodology