# K221695: 3M Filtek Supreme Flowable Restorative

- Pathway: 510(k) (Traditional)
- Applicant: 3M Company Espe Dental Products
- Decided: Jun 13, 2022 after 3 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 K042819 (2004). 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)
- K100235: Filtek Supreme Ultra Flowable Restorative, 3M Company (2010) Summary page 5.
- K042819: Tetric Evoceram, Ivoclar Vivadent, Inc. (2004) Summary page 5.

## Most influential descendants
- K261695: Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF) (2026), 0 descendants of its own

## Indications for use
* Direct Restoration of all cavity classes (I-V) * Base/liner under direct restorations * Repair of small defects in esthetic indirect restorations * Repair of resin and acrylic temporary materials * Pit and fissure sealant

Source page: https://510kreport.com/device/K221695
Methodology: https://510kreport.com/methodology