# K141081: Filtek Bulk Fill Posterior Restroative

- Pathway: 510(k) (Traditional)
- Applicant: 3M Espe Dental Products
- Decided: May 8, 2014 after 13 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 K083610 (2008). 3 ancestors in all.
9 later devices descend from it; 3 cite 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)
- K083610: Filtek Supreme Ultra Universal Restorative, 3M Company (2008) Summary page 1.
- K091023: Metamorphosis, Kerr Corporation (2009) Summary page 1.
- K111958: Tetric Evoceram Bulk Fill, Ivoclar Vivadent, Inc. (2011) Summary page 1.

## Most influential descendants
- K183476: 3M Filtek Universal Restorative (2019), 5 descendants of its own
- K241147: Any-Com (2024), 1 descendant of its own
- K191306: Llis, Vittra APS (2019), 1 descendant of its own
- K163207: Filtek One Bulk Fill Restorative (2016), 1 descendant of its own
- K250823: Any-Com Flow (2025), 0 descendants of its own

## Indications for use
Direct anterior and posterior restorations (including occlusal surfaces) Base/liner under direct restorations Core build-ups Splinting Restorations of deciduous teeth Extended fissure sealing in molars and premolars Repair of defects in porcelain restorations, enamel, and temporaries

Source page: https://510kreport.com/device/K141081
Methodology: https://510kreport.com/methodology