# K252465: Any-Core

- Pathway: 510(k) (Traditional)
- Applicant: Mediclus Co., Ltd.
- Decided: Dec 5, 2025 after 121 days
- Product code: EBF (Material, Tooth Shade, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3690
- 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 K872510 (1987). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012307: Luxacore/Luxacore Dual, Dmg USA, Inc. (2001) Summary page 5.

## Indications for use
- Repair material for provisionals - Cement for pins and posts - Semipermanent restorative material (e.g., in childrens' teeth)

Source page: https://510kreport.com/device/K252465
Methodology: https://510kreport.com/methodology