# K241147: Any-Com

- Pathway: 510(k) (Traditional)
- Applicant: Mediclus Co., Ltd.
- Decided: Sep 26, 2024 after 154 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: 3 generations back to K083610 (2008). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183476: 3M Filtek Universal Restorative, 3M Espe Dental Products (2019) Summary page 5.

## Most influential descendants
- K250823: Any-Com Flow (2025), 0 descendants of its own

## Indications for use
- Anterior and posterior restorations - Core build-up - Indirect restorations for inlays, onlays and veneers.

Source page: https://510kreport.com/device/K241147
Methodology: https://510kreport.com/methodology
