# K100235: Filtek Supreme Ultra Flowable Restorative

- Pathway: 510(k) (Traditional)
- Applicant: 3M Company
- Decided: May 12, 2010 after 106 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.
21 later devices descend from it; 9 cite it directly.
0 of 22 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 LVR System: named in the summary without a submission number
- (no number) Revolution Formula 2: named in the summary without a submission number

## Most influential descendants
- K120453: Filtek Bulk Fill Flowable Restorative (2012), 8 descendants of its own
- K182580: Novidia Flowable Composite (2019), 3 descendants of its own
- K182921: Infinix Universal Composite (2019), 2 descendants of its own
- K182714: Novidia Bulk Fill Flow Composite (2019), 2 descendants of its own
- K213339: DENU Composite Resin, DENU Flow Resin (2022), 1 descendant of its own

## Indications for use
Class III and V restorations Restoration of minimally invasive cavity preparations (including small, non stress-bearing occiusal restorations) Base/liner under direct restorations Repair of small defects in esthetic indirect restorations Pit and fissure sealant Undercut blockout Repair of resin and acrylic temporary materials

Source page: https://510kreport.com/device/K100235
Methodology: https://510kreport.com/methodology