# K180463: Apoller Flow Light Cure Flowable Composite

- Pathway: 510(k) (Abbreviated)
- Applicant: Greenway Yw, LLC
- Decided: Nov 14, 2018 after 266 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 5.

## Indications for use
Class Il 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/K180463
Methodology: https://510kreport.com/methodology