# K102603: SA Flowable Adhesive

- Pathway: 510(k) (Abbreviated)
- Applicant: Dmg USA, Inc.
- Decided: Nov 17, 2010 after 68 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: 2 generations back to K031877 (2003). 2 ancestors in all.
1 later device descends 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)
- K072545: Artiste SE Flowable Composite, Model N280, Pentron Clinical Technologies (2007) Summary page 1.

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

## Indications for use
SA Flowable Composite is a self-etching, self-adhesive, light-curing, flowable composite. SA Flowable Composite applications include: * Minor restorations of class I (without contact point) * Underfillings of classes l and 11 * Fissure sealing * Repairs of composite restorations * Modifications to temporaries and long-term temporaries * Blocking out and filling of undercuts

Source page: https://510kreport.com/device/K102603
Methodology: https://510kreport.com/methodology