# K051818: Beautifil Flow

- Pathway: 510(k) (Traditional)
- Applicant: Shofu Dental Corp.
- Decided: Aug 3, 2005 after 29 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
BEAUTIFIL Flow is a radiopaque, light-cured fluoride releasing flowable restorative material for esthetic restoration intended for use in anterior restoration involving class III, class IV, class V (such as cervical caries, root surface caries, and wedge shaped defects), small posterior restoration (class I and II) without occlusal stress-bearing, and restoration of deciduous.

Source page: https://510kreport.com/device/K051818
Methodology: https://510kreport.com/methodology