# K023814: Gradia Direct

- Pathway: 510(k) (Traditional)
- Applicant: GC America, Inc.
- Decided: Jan 30, 2003 after 76 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.
12 later devices descend from it; 1 cites it directly.
0 of 13 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
- K061860: Clearfil Majesty Esthetic (2006), 11 descendants of its own
- K063595: Clearfil Majesty Posterior (2007), 4 descendants of its own
- K121583: Clearfil Majesty Flow (2012), 3 descendants of its own
- K071169: Clearfil Majesty Posterior PLT (2007), 1 descendant of its own
- K192178: R&D Series Nova Compo N (2019), 0 descendants of its own

## Indications for use
GRADIA DIRECT is a visible light-cured micro-filled hybrid resin to be used for the recommended indications listed below: GRADIA DIRECT ANTERIOR: 1. Direct restorative for Class III, IV and V cavities. 2. Direct restorative for wedge-shaped defects and root surface cavities. 3. Direct restorative for veneers and diastema closure. GRADIA DIRECT POSTERIOR: 1. Direct restorations for Class I and II cavities.

Source page: https://510kreport.com/device/K023814
Methodology: https://510kreport.com/methodology