# K080479: Dental Ceramic

- Pathway: 510(k) (Abbreviated)
- Applicant: Dmg USA, Inc.
- Decided: May 21, 2008 after 89 days
- Product code: EIH (Powder, Porcelain)
- Device class: 2
- Regulation: 21 CFR 872.6660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K980986 (1998). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980986: Procad, Ivoclar USA, Inc. (1998) Summary page 1.

## Indications for use
The Dental Ceramic is indicated for use with the: * preparation of inlays · preparation of onlays · preparation of veneers * preparation of crowns The Dental Ceramic is indicated for use with CEREC devices marketed by Sirona, Bensheim, Germany. The blocks are compatible with all CEREC devices up to CEREC 3 and inLab but not compatible with the CEREC model MC XL and Inlab model MC XL.

Source page: https://510kreport.com/device/K080479
Methodology: https://510kreport.com/methodology