# K974131: ALERT

- Pathway: 510(k) (Traditional)
- Applicant: Jeneric/Pentron, Inc.
- Decided: Dec 17, 1997 after 44 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Tooth colored posterior restorative material For usage in a similar situation that would be applicable to an amalgam restoration.

Source page: https://510kreport.com/device/K974131
Methodology: https://510kreport.com/methodology