# K210421: Diafil & Diafil Capsule

- Pathway: 510(k) (Special)
- Applicant: DiaDent Group International
- Decided: Jun 28, 2021 after 137 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). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 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 4.
- K192392: DiaPlus, DiaDent Group International (2020) Summary page 4.
- K192273: DIAETCH Economic Package Type A, DIATECH Regular Package, DIAETCH Refill Package Type A, DIAETCH Intro Kit, DiaDent Group International (2020) Summary page 4.

## Indications for use
DiaFil & DiaFil Capsule 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/K210421
Methodology: https://510kreport.com/methodology