# K261166: Dia-Cem

- Pathway: 510(k) (Traditional)
- Applicant: DiaDent Group International
- Decided: Jul 9, 2026 after 91 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: 10 generations back to K931812 (1993). 50 ancestors in all.
No later device cites it as a predicate yet.
0 of 51 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082449: Biscem Translucent, Model D-45011; Biscem Opaque, Model D-45012, Bisco, Inc. (2008) Summary page 5.
- K171449: Metacem, Meta Biomed Co., Ltd. (2018) Summary page 5.

## Indications for use
- Resin crowns, bridges, inlays and onlays - Glass ceramic, porcelain crowns, inlays and onlays (includes alumina and zirconia) - Metal crowns, bridges, inlays and onlays (includes porcelain fused to metal and composite to metal) - Metal (prefabricated or cast) and fiber posts

Source page: https://510kreport.com/device/K261166
Methodology: https://510kreport.com/methodology