# K092572: Core*IT Dual

- Pathway: 510(k) (Traditional)
- Applicant: Spident Co., Ltd.
- Decided: Aug 26, 2009 after 5 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: 2 generations back to K872510 (1987). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012307: Luxacore/Luxacore Dual, Dmg USA, Inc. (2001). Our reading of the summary gave K102307, FDA’s number for Genoss Collagen Membrane Model GCM1020, GCM3040 Total 6… (Genoss Co., Ltd.), decided May 4, 2011, after this device. Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “LuxaCore Dual”. Summary page 1.

## Most influential descendants
- K262982: Core·it Dual (2026), 0 descendants of its own

## Indications for use
The principal use for Core-it Dual is as a core material either with adhesives or with pins or posts. Core-it Dual can also be used for: · Lining of abutments to dentures · 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 children's teeth)

Source page: https://510kreport.com/device/K092572
Methodology: https://510kreport.com/methodology