# K151094: Mosaic Universal Composite

- Pathway: 510(k) (Traditional)
- Applicant: Ultradent Products, Inc.
- Decided: Jul 21, 2015 after 89 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: 1 generation back to K981647 (1998). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083610: Filtek Supreme Ultra Universal Restorative, 3M Company (2008) Summary page 4.
- K981647: 3M Dent II System, 3M Company (1998) Summary page 4.

## Most influential descendants
- K240694: FORMA Composite (Shade A3D) (2024), 0 descendants of its own

## Indications for use
Mosaic is used for direct and indirect restorations (inlays, onlays, and veneers) in both the anterior and posterior regions.

Source page: https://510kreport.com/device/K151094
Methodology: https://510kreport.com/methodology