# K180613: Estelite Universal Flow

- Pathway: 510(k) (Traditional)
- Applicant: Tokuyama Dental Corporation
- Decided: Jul 12, 2018 after 126 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: 5 generations back to K002863 (2001). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161353: ESTELITE BULK FILL Flow, Tokuyama Dental Corporation (2017) Summary page 7.

## Indications for use
The ESTELITE UNIVERSAL FLOW device is indicated for use as a tooth shade resin material in dental procedures, such as: - Direct anterior and posterior restorations - Cavity base or liner - Blocking out cavity undercuts before fabricating indirect restorations - Repair of porcelain/composite

Source page: https://510kreport.com/device/K180613
Methodology: https://510kreport.com/methodology