# K100510: Ceramir Crown & Bridge

- Pathway: 510(k) (Special)
- Applicant: Doxa AB
- Decided: Mar 25, 2010 after 31 days
- Product code: EMA (Cement, Dental)
- Device class: 2
- Regulation: 21 CFR 872.3275
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K897188 (1990). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081405: Xeracem, Doxa Dental AB (2008) Summary page 1.

## Indications for use
Ceramir Crown & Bridge is intended for the permanent cementation of * Porcelain Fused to Metal Crowns and Bridges * Metal (gold etc.) crowns and bridges * Gold inlays and onlays * Cast or prefabricated metal posts * Strengthened core all-zirconia or all-alumina ceramic crowns and bridges

Source page: https://510kreport.com/device/K100510
Methodology: https://510kreport.com/methodology