# K020342: Unifil Flow

- Pathway: 510(k) (Traditional)
- Applicant: GC America, Inc.
- Decided: Mar 28, 2002 after 55 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
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K103190: Profil Composites (Profil, Profil Flow) (2011), 1 descendant of its own
- K220077: IMICRYL Composite, Composite Flow Materials (2022), 0 descendants of its own
- K151541: G-Fix (2015), 0 descendants of its own

## Indications for use
GC UniFil Flow is intended to be used for small class I & II restorations. And Class III, IV and V restorations. Other uses include: Base and Liner, sealing for hypersensitivity, Pit and fissure sealar fixation of mobile teeth and repair of resin composite.

Source page: https://510kreport.com/device/K020342
Methodology: https://510kreport.com/methodology