# K070702: Fusion Resin Cement and Core Kit

- Pathway: 510(k) (Traditional)
- Applicant: Denali Corporation
- Decided: May 10, 2007 after 58 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. The FDA summary names its predicate without a number.
- (no number) Clearfil Photo Core, Kuraray: named in the summary without a submission number
- (no number) Rebilda LC, Voco: named in the summary without a submission number
- (no number) SuperCure, Centrix: named in the summary without a submission number
- (no number) EnCore, Centrix: named in the summary without a submission number

## Indications for use
Fusion Core is a high strength core material that offers the convenience of light curing with excellent depth of cure that allows either the layering or the core form approach to build-up. Fusion Core cuts just like dentin without clogging the cutting bur as many other BIS-GMA containing materials. Fusion Core contains no BIS-GMA and is based upon a hydrophilic resin/filler combination.

Source page: https://510kreport.com/device/K070702
Methodology: https://510kreport.com/methodology