# K150623: Nanova Flowable Composite

- Pathway: 510(k) (Traditional)
- Applicant: Nanova Biomaterials, Inc.
- Decided: Jun 18, 2015 after 99 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 K100235 (2010). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 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 4.

## Indications for use
Class III and V restorations Restoration of minimally invasive cavity preparations (including small, non stress-bearing occlusal 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/K150623
Methodology: https://510kreport.com/methodology