# K161353: ESTELITE BULK FILL Flow

- Pathway: 510(k) (Traditional)
- Applicant: Tokuyama Dental Corporation
- Decided: Apr 3, 2017 after 322 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: 4 generations back to K002863 (2001). 8 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 11 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 5.
- K070215: Tokuyama Bond Force, Tokuyama Dental Corporation (2007) Summary page 8.
- K110178: Estelite Color, Tokuyama Dental Corporation (2011) Summary page 8.

## Most influential descendants
- K203598: Omnichroma Flow Bulk (2021), 0 descendants of its own
- K180613: Estelite Universal Flow (2018), 0 descendants of its own

## Indications for use
For use as a tooth shade resin material in dental procedures, such as: - Direct anterior and posterior restorations - Cavity lining - Blocking out cavity undercuts before fabricating indirect restorations - Repair of porcelain/composite

Source page: https://510kreport.com/device/K161353
Methodology: https://510kreport.com/methodology