# K183476: 3M Filtek Universal Restorative

- Pathway: 510(k) (Traditional)
- Applicant: 3M Espe Dental Products
- Decided: Jan 2, 2019 after 16 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: 2 generations back to K083610 (2008). 4 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141081: Filtek Bulk Fill Posterior Restroative, 3M Espe Dental Products (2014) Summary page 4.

## Most influential descendants
- K241147: Any-Com (2024), 1 descendant of its own
- K191306: Llis, Vittra APS (2019), 1 descendant of its own
- K250823: Any-Com Flow (2025), 0 descendants of its own
- K231523: EsCom250 (2023), 0 descendants of its own
- K210231: Vittra APS Unique (2021), 0 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/K183476
Methodology: https://510kreport.com/methodology