# K110178: Estelite Color

- Pathway: 510(k) (Traditional)
- Applicant: Tokuyama Dental Corporation
- Decided: Apr 5, 2011 after 74 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: 3 generations back to K002863 (2001). 6 ancestors in all.
3 later devices descend from it; 1 cites 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)
- K961284: KOLOR +, Sybron Dental Specialties, Inc. (1996)
- K072746: E-1 Esthetic Composite System, Tokuyama Dental Corporation (2007) Summary page 2.
- K080940: Estelite Sigma Quick, Tokuyama Dental Corporation (2008) Summary page 2.

## Most influential descendants
- K161353: ESTELITE BULK FILL Flow (2017), 2 descendants of its own
- K203598: Omnichroma Flow Bulk (2021), 0 descendants of its own
- K180613: Estelite Universal Flow (2018), 0 descendants of its own

## Indications for use
The ESTELITE COLOR tooth shade resin material is for masking discolorations and making individualized shade characterizations in direct and indirect resin restorations, applied below or in between layers of the composite restoration.

Source page: https://510kreport.com/device/K110178
Methodology: https://510kreport.com/methodology