# K090701: Empress Direct

- Pathway: 510(k) (Traditional)
- Applicant: Ivoclar Vivadent, Inc.
- Decided: Apr 29, 2009 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
Anterior restorations (Class III, IV) Tooth Neck restorations (Class V, e.g. cervical caries, root erosion, wedge-shaped defects) Restorations in the posterior region (Class I and II) Direct Veneers Corrections of tooth positions and tooth shape (e.g. diastema closure, closure of interdental "black triangles," lengthening of the incisal edge

Source page: https://510kreport.com/device/K090701
Methodology: https://510kreport.com/methodology