# K993514: Definite

- Pathway: 510(k) (Traditional)
- Applicant: Degussa - Ney Dental, Inc.
- Decided: Feb 24, 2000 after 129 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
Definite® is a light cured composite intended to be used for all classes of restorations from class I to class V. Since Definite® is light cured, it is offered as a single paste system in compules. The system consists of the filling material Definite® and the self etching adhesive Etch&Prime® 3.0.

Source page: https://510kreport.com/device/K993514
Methodology: https://510kreport.com/methodology