# K033773: Concept HP Add-on; Concept HP Enamel

- Pathway: 510(k) (Traditional)
- Applicant: Ivoclar Vivadent, AG
- Decided: Jan 15, 2004 after 43 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
Concept HP Add-On is light cured resin material for the preparation of indirect inlay and onlay dental restorations Concept HP Enamel is heat and pressure cured resin material to be used for the preparation of indirect inlay and onlay dental restorations. The materials are contraindicated for: Veneers Metal supported crown & bridges Conventionally cemented metal-free restorations Patients with occlusal dysfunction, parafunctions Patients with insufficient oral hygiene

Source page: https://510kreport.com/device/K033773
Methodology: https://510kreport.com/methodology