# K101603: Beautifil Flow Plus

- Pathway: 510(k) (Traditional)
- Applicant: Shofu Dental Corp.
- Decided: Aug 23, 2010 after 76 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K182288: TPH Spectra ST Flowable Composite Restorative (2018), 0 descendants of its own

## Indications for use
Beautifil Flow Plus is a light-curing dental filling material having low viscosity intended to directly restore cavities and lesions (except for root canal filling), and to repair fractured artificial crowns.

Source page: https://510kreport.com/device/K101603
Methodology: https://510kreport.com/methodology