# K130672: Optiflow II Flowable Composite, LC

- Pathway: 510(k) (Traditional)
- Applicant: Pac-Dent International, Inc.
- Decided: Aug 13, 2013 after 154 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 K833810 (1984). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 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)
- K833810: Curay-Match Paint-on Composite Restor, Scientific Pharmaceuticals, Inc. (1984) Summary page 2.

## Indications for use
OptiFlow 11Flowable Composite, LC is intended for use as: * Repair of minimally invasive cavity (including non-stress bearing areas) * Pit and fissure sealant * Class Ill-V restorations * Repair of porcelain restorations * Repair of ceramic/composite veneers

Source page: https://510kreport.com/device/K130672
Methodology: https://510kreport.com/methodology