# K083610: Filtek Supreme Ultra Universal Restorative

- Pathway: 510(k) (Traditional)
- Applicant: 3M Company
- Decided: Dec 17, 2008 after 9 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.
64 later devices descend from it; 11 cite it directly.
0 of 65 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) 3M Espe Haur: named in the summary without a submission number

## Most influential descendants
- K110131: Lava Ultimate Cad/Cam Restorative for Cerec / E4D, Lava Ultimate Implant Crown Restorative (2011), 39 descendants of its own
- K133824: Cerasmart (2014), 32 descendants of its own
- K160425: CAD/CAMouflage Milling Bock (2016), 26 descendants of its own
- K162537: CAD/CAMouflage Milling Block (2016), 25 descendants of its own
- K201668: VarseoSmile Crown plus (2020), 24 descendants of its own

## Indications for use
Direct anterior and posterior restorations (including occlusal surfaces) Core Build-ups Splinting Indirect restorations including inlays, onlays and veneers

Source page: https://510kreport.com/device/K083610
Methodology: https://510kreport.com/methodology