# K192510: DIAFIL & DIAFIL Capsule

- Pathway: 510(k) (Traditional)
- Applicant: DiaDent Group International
- Decided: Mar 20, 2020 after 190 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: 4 generations back to K943168 (1994). 5 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042124: Denfil, Vericom Co., Ltd. (2004) Summary page 4.

## Most influential descendants
- K261093: Diafil (2026), 0 descendants of its own
- K210421: Diafil & Diafil Capsule (2021), 0 descendants of its own

## 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

Source page: https://510kreport.com/device/K192510
Methodology: https://510kreport.com/methodology