# K072545: Artiste SE Flowable Composite, Model N280

- Pathway: 510(k) (Traditional)
- Applicant: Pentron Clinical Technologies
- Decided: Oct 26, 2007 after 46 days
- Product code: EBF (Material, Tooth Shade, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3690
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K031877 (2003). 1 ancestor in all.
2 later devices descend 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)
- K031877: Embrace Wet-Bond Restorative Material, Pulpdent Corporation (2003) Summary page 1.

## Most influential descendants
- K102603: SA Flowable Adhesive (2010), 1 descendant of its own
- K231263: Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal; Magna NT (2024), 0 descendants of its own

## Recalls of this device
- Aug 19, 2010 · Not classified · Z-1115-2012: A recall was initiated because Pentron Clinical has confirmed that the Fusio Liquid Dentin is not as flowable as ideally expected.

## Indications for use
Artiste SE Flowable Composite product is a self-etch, self-adhesive flowable resin composite indicated for light-cured dental restorations. Applications include: Self-etch base liner Restorations of carious lesions Class 1, III, and V cavity preparations Pit and fissure sealant.

Source page: https://510kreport.com/device/K072545
Methodology: https://510kreport.com/methodology