# K262982: Core·it Dual

- Pathway: 510(k) (Special)
- Applicant: Spident Co., Ltd.
- Decided: Sep 21, 2026 after 25 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: 3 generations back to K872510 (1987). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092572: Core*IT Dual, Spident Co., Ltd. (2009) Summary page 5.

## 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: - Luting 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 childrens' teeth)

Source page: https://510kreport.com/device/K262982
Methodology: https://510kreport.com/methodology