# K980054: Palfique Estelite

- Pathway: 510(k) (Traditional)
- Applicant: Tokuyama America, Inc.
- Decided: Apr 27, 1998 after 111 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Palfique Estelite: named in the summary without a submission number
- (no number) Scotchbond Multipurpose Adhesive: named in the summary without a submission number
- (no number) 3M Brand Restorative Z-100: named in the summary without a submission number
- (no number) Clearfil AP-X & Liner Bond II: named in the summary without a submission number

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

Source page: https://510kreport.com/device/K980054
Methodology: https://510kreport.com/methodology