# K261071: DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g)

- Pathway: 510(k) (Traditional)
- Applicant: DiaDent Group International
- Decided: May 19, 2026 after 48 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 K010267 (2001). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173275: Omnichroma, Tokuyama Dental Corporation (2018) Summary page 5.

## Indications for use
- Base under Class I, II direct restorations - Liner under direct restorative materials - Repair of composite/ceramic veneers - Restorations of small posterior cavities - Undercut block-out - Pit & Fissure sealant

Source page: https://510kreport.com/device/K261071
Methodology: https://510kreport.com/methodology