# K240694: FORMA Composite (Shade A3D)

- Pathway: 510(k) (Traditional)
- Applicant: Ultradent Products, Inc.
- Decided: Mar 15, 2024 after 1 day
- 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: 2 generations back to K981647 (1998). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151094: Mosaic Universal Composite, Ultradent Products, Inc. (2015) Summary page 5.

## Indications for use
FORMA Composite is designed for restorations in anterior and posterior teeth.

Source page: https://510kreport.com/device/K240694
Methodology: https://510kreport.com/methodology