# K202063: TrusFIL Universal Composite Restorative

- Pathway: 510(k) (Traditional)
- Applicant: Rizhao Huge Biomaterials Company, Ltd.
- Decided: Oct 6, 2021 after 436 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 K083610 (2008). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083610: Filtek Supreme Ultra Universal Restorative, 3M Company (2008) Summary page 4.

## Most influential descendants
- K242816: Quantium (2024), 0 descendants of its own

## Indications for use
TrusFIL Universal Composite Restorative is a visible light curing dental restorative material indicated for: - Direct anterior and posterior restorations (including occlusal surfaces); - Core Build-ups; - Splinting; - Indirect restorations including inlays, onlays and veneers.

Source page: https://510kreport.com/device/K202063
Methodology: https://510kreport.com/methodology