# K012307: Luxacore/Luxacore Dual

- Pathway: 510(k) (Abbreviated)
- Applicant: Dmg USA, Inc.
- Decided: Aug 23, 2001 after 31 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: 1 generation back to K872510 (1987). 4 ancestors in all.
9 later devices descend from it; 6 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K932826: Centrix's Encore Composite Resin Core Paste W\Fluo, Alpha-Dent (1994) Summary page 1.
- K872510: Den-Mat Tenure, Den-Mat Corp. (1987) Summary page 1.
- K964000: Bisfil 2B, Bisco, Inc. (1996) Summary page 1.
- K982201: Zenith Luxacore Automix Core Material (Multiple), Foremost Dental Mfg., Inc. (1998) Summary page 1.

## Most influential descendants
- 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
- K260805: Dual Core (2026), 0 descendants of its own

## Indications for use
The principal use for LuxaCore and LuxaCore Dual is as a core material either with adhesives or with pins or posts. LuxaCore and LuxaCore Dual can also be used for: Splinting of teeth in combination with wires, Kevlar or Ribbond-type materials Repair material for provisionals Bite registration material. Build up material for plastic bite rails (occlusal individualisation). Cement for pins and posts Semipermanent restorative material (e.g., in childrens’ teeth) LuxaCore can be used for luting of abutments to dentures.

Source page: https://510kreport.com/device/K012307
Methodology: https://510kreport.com/methodology