# K153325: Gradia Plus

- Pathway: 510(k) (Traditional)
- Applicant: GC America, Inc.
- Decided: Jul 12, 2016 after 236 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 K042819 (2004). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001518: Gradia, GC America, Inc. (2000) Summary page 4.
- K033808: Gradia Gum, GC America, Inc. (2004) Summary page 4.
- K123631: MFP-051, GC America, Inc. (2013) Summary page 4.
- K133836: Optiglaze Color, GC America, Inc. (2014) Summary page 4.

## Indications for use
1. Crown and Bridgework (with metal backing) 2. Metal free restorations: Jacket Crowns, Inlays, Onlays and Laminated Veneers 3. Implant superstructures 4. Reproduction of gum tissue for crown restorations

Source page: https://510kreport.com/device/K153325
Methodology: https://510kreport.com/methodology