# K254201: Any-Cem

- Pathway: 510(k) (Traditional)
- Applicant: Mediclus Co., Ltd.
- Decided: Aug 13, 2026 after 227 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 K082449 (2008). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231552: Dia-Cem, DiaDent Group International (2023) Summary page 5.

## Indications for use
- Metal crowns, bridges, inlays and onlays - Resin crowns, bridges, inlays and onlays - All ceramic

Source page: https://510kreport.com/device/K254201
Methodology: https://510kreport.com/methodology