# K120768: ES Flow

- Pathway: 510(k) (Traditional)
- Applicant: Spident Co., Ltd.
- Decided: May 3, 2012 after 50 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: 2 generations back to K002863 (2001). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051808: Estelite Flow Quick, Tokuyama Dental Corporation (2005) Summary page 1.

## Indications for use
EsFlow is a low viscous, light cured hybrid composite dental tooth shade resin material. It is intended for use in various dental procedures, including direct anterior and posterior restorations (particularly for small/shallow/tunnel shaped cavities), as the first layer of direct restorations, blocking out cavity undercuts before fabricating indirect restorations, and repair of porcelain/composite materials.

Source page: https://510kreport.com/device/K120768
Methodology: https://510kreport.com/methodology