# K051808: Estelite Flow Quick

- Pathway: 510(k) (Traditional)
- Applicant: Tokuyama Dental Corporation
- Decided: Aug 8, 2005 after 34 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: 1 generation back to K002863 (2001). 1 ancestor in all.
8 later devices descend from it; 4 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002863: Palfique Estelite LV, Tokuyama America, Inc. (2001) Summary page 2.

## Most influential descendants
- K080940: Estelite Sigma Quick (2008), 5 descendants of its own
- K072746: E-1 Esthetic Composite System (2007), 4 descendants of its own
- K110178: Estelite Color (2011), 3 descendants of its own
- K161353: ESTELITE BULK FILL Flow (2017), 2 descendants of its own
- K203598: Omnichroma Flow Bulk (2021), 0 descendants of its own

## Indications for use
For use as a tooth shade resin material in dental procedures

Source page: https://510kreport.com/device/K051808
Methodology: https://510kreport.com/methodology