# K033808: Gradia Gum

- Pathway: 510(k) (Traditional)
- Applicant: GC America, Inc.
- Decided: Feb 2, 2004 after 56 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.
2 later devices descend from it; 2 cite it directly.
0 of 3 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
- K231389: Harvest Dental HD Gum Strip (2023), 0 descendants of its own
- K153325: Gradia Plus (2016), 0 descendants of its own

## Indications for use
GRADIA GUM is a light-cured composite resin specifically used for the reproduction of the gum on crown and bridge prostheses.

Source page: https://510kreport.com/device/K033808
Methodology: https://510kreport.com/methodology