# K121230: Ips Empress Direct Color Ips Empress Direct Opaque

- Pathway: 510(k) (Traditional)
- Applicant: Ivoclar Vivadent, AG
- Decided: Aug 29, 2012 after 127 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K253036: Light-curing Coloring Materials (ALCM) (2026), 0 descendants of its own

## Indications for use
IPS Empress Direct Color: Individualized characterization of direct and lab-fabricated composite resin restorations; masking of discolored tooth structure; characterization of chairside CAD/CAM veneers. IPS Empress Direct Opaque: Masking exposed metal surfaces when repairing defective ceramic and composite veneers intraorally; Masking of discolored tooth structure.

Source page: https://510kreport.com/device/K121230
Methodology: https://510kreport.com/methodology