# K980051: Palfique Estelite Paste

- Pathway: 510(k) (Traditional)
- Applicant: Tokuyama America, Inc.
- Decided: Feb 24, 1998 after 49 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
No predicates in its family tree.
7 later devices descend from it; 2 cite 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)
- None. The FDA summary names no predicate by number.

## 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/K980051
Methodology: https://510kreport.com/methodology