# K163207: Filtek One Bulk Fill Restorative

- Pathway: 510(k) (Traditional)
- Applicant: 3M Company
- Decided: Nov 28, 2016 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: 2 generations back to K083610 (2008). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 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
- K221255: SimpliShade Bulk Fill, SimpliShade Bulk Fill Flow (2022), 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 Indirect restorations including inlays, onlays and veneers 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/K163207
Methodology: https://510kreport.com/methodology