# K081405: Xeracem

- Pathway: 510(k) (Abbreviated)
- Applicant: Doxa Dental AB
- Decided: Aug 21, 2008 after 94 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: 1 generation back to K897188 (1990). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K897188: Ketac-Cem Maxicap, Espe GmbH (Us) (1990) Summary page 1.
- K011839: Doxadent Dental Composite, Models a, B, C, 12A, 12B, 12C, 6A, 6B, and 6C, Doxa Certex AB (2002) Summary page 1.

## Most influential descendants
- K100510: Ceramir Crown & Bridge (2010), 0 descendants of its own

## Indications for use
XeraCem is intended for the permanent cementation of: Porcelain Fused to Metal Crowns and Bridges Metal (gold etc.) crowns and bridges Gold inlays and onlays Prefabricated metal and cast posts Prefabricated metal provisional crowns All-zirconia or all-alumina ceramic crowns and bridges

Source page: https://510kreport.com/device/K081405
Methodology: https://510kreport.com/methodology