# K221510: TrusFIL-Flow Flowable Composite Restorative

- Pathway: 510(k) (Traditional)
- Applicant: Rizhao Huge Biomaterials Company, Ltd.
- Decided: Oct 12, 2022 after 141 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: 1 generation back to K100235 (2010). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100235: Filtek Supreme Ultra Flowable Restorative, 3M Company (2010) Summary page 4.

## Indications for use
TrusFIL-Flow Flowable Composite Restorative is a visible light curing dental restorative material indicated for: - Class 1H and V restorations - Restoration of minimally invasive cavity preparations (including small, non stress-bearing occlusal restorations) - Base/liner under direct restorations - Repair of small defects in indirect restorations - Pit and fissure sealant - Undercut blockout - Repair of resin and acrylic temporary materials

Source page: https://510kreport.com/device/K221510
Methodology: https://510kreport.com/methodology