# K982201: Zenith Luxacore Automix Core Material (Multiple)

- Pathway: 510(k) (Traditional)
- Applicant: Foremost Dental Mfg., Inc.
- Decided: Aug 10, 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.
11 later devices descend from it; 2 cite it directly.
0 of 12 devices 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.

## Most influential descendants
- K012307: Luxacore/Luxacore Dual (2001), 9 descendants of its own
- K143104: Visalys Core, Visalys PL-Core, Visalys PL-Core-C, Visalys PL-Core-X (2015), 1 descendant of its own
- K092572: Core*IT Dual (2009), 1 descendant of its own
- K041960: Composite/Compomer Repair Kit (2004), 1 descendant of its own
- K262982: Core·it Dual (2026), 0 descendants of its own

Source page: https://510kreport.com/device/K982201
Methodology: https://510kreport.com/methodology