# K072746: E-1 Esthetic Composite System

- Pathway: 510(k) (Traditional)
- Applicant: Tokuyama Dental Corporation
- Decided: Dec 4, 2007 after 68 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). 3 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980051: Palfique Estelite Paste, Tokuyama America, Inc. (1998) Summary page 2.
- K051808: Estelite Flow Quick, Tokuyama Dental Corporation (2005) Summary page 2.

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

## Indications for use
The E-I ESTHETIC COMPOSITE SYSTEM is for use as a tooth shade resin material in dental procedures.

Source page: https://510kreport.com/device/K072746
Methodology: https://510kreport.com/methodology