# K082171: Gradia Core

- Pathway: 510(k) (Traditional)
- Applicant: GC America, Inc.
- Decided: Oct 30, 2008 after 90 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.
33 later devices descend from it; 1 cites it directly.
0 of 34 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
- K133824: Cerasmart (2014), 32 descendants of its own
- K160425: CAD/CAMouflage Milling Bock (2016), 26 descendants of its own
- K162537: CAD/CAMouflage Milling Block (2016), 25 descendants of its own
- K201668: VarseoSmile Crown plus (2020), 24 descendants of its own
- K202846: Tera Harz (2021), 13 descendants of its own

## Indications for use
GRADIA CORE consists of the two articles, GRADIA CORE cartridge and GRADIA CORE self-etching bond. GRADIA CORE cartridge is a two-paste (base and catalyst) type, dual-cured composite iresin filled in double syringe to provide auto-mixing system. "GRAD IACORE self-etching bond is a two-liquid (A and B), dual-cured self-etching bonding agent to be used for bonding of GRADIA CORE cartridge to the prepared tooth. GRADIA CORE is intended to be used for restoration, core build-up and post cementation.

Source page: https://510kreport.com/device/K082171
Methodology: https://510kreport.com/methodology