# K231263: Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal; Magna NT

- Pathway: 510(k) (Traditional)
- Applicant: Prevest Denpro Limited
- Decided: Jan 5, 2024 after 248 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: 3 generations back to K031877 (2003). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201707: Opallis, Opallis Flow, Dentscare Ltda (2020) Summary page 7.
- K102703: Build-IT Total Core, Pentron Clinical (2011) Summary page 7.
- K993783: Tetric Flow, Ivoclar North America, Inc. (1999) Summary page 7.
- K102603: SA Flowable Adhesive, Dmg USA, Inc. (2010) Summary page 7.

## Indications for use
Fusion Core DC Flo is indicated for use as core build up material on vital and non-vital teeth, sealing root canal openings, cavity floor liner, post cementation, restorative material, and as a dentin replacement material. Fusion Flo is indicated for direct filling of class V (cervical caries, root erosions, and wedge shaped defects), anterior restorations( Class III and IV), small posterior restorations, repair of composite/ceramic veneers, and blocking out of undercuts. Fusion Flo SE is indicated for direct filling of class V (cervical caries, root erosions, wedge shaped defects), anterior restorations (Class III and IV), small posterior restorations. Fusion I-Seal is indicated for Class I and Class II restorations, as a liner under composite restorations, and as a pit and fissure sealant. Magma NT is indicated for direct restoration in anterior and posterior teeth classes I, II, III, IV and V, and porcelain/composite repairs.

Source page: https://510kreport.com/device/K231263
Methodology: https://510kreport.com/methodology