# K261093: Diafil

- Pathway: 510(k) (Traditional)
- Applicant: DiaDent Group International
- Decided: Jun 2, 2026 after 61 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: 5 generations back to K943168 (1994). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192510: DIAFIL & DIAFIL Capsule, DiaDent Group International (2020) Summary page 5.

## Indications for use
A composite material which has resin organic and inorganic fillers or complex fillers as ingredients, which are being used for aesthetic restoration by getting polymerized directly in the oral cavity. -. Direct anterior and posterior restorations -. Core build-ups -. Splinting

Source page: https://510kreport.com/device/K261093
Methodology: https://510kreport.com/methodology