# K170873: Medi Galaxy Flow, Medi Classic, Medi Pearl, Medi Jupiter, Medi Opaque Posterior, Medi White Pearl

- Pathway: 510(k) (Traditional)
- Applicant: Swissmeditec GmbH
- Decided: Oct 2, 2017 after 193 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: 9 generations back to K931812 (1993). 26 ancestors in all.
No later device cites it as a predicate yet.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121583: Clearfil Majesty Flow, Kuraray Noritake Dental, Inc. (2012) Summary page 5.

## Indications for use
1) Direct anterior and posterior restorations (including occlusal surfaces) 2) Direct veneers 3) Correction of tooth position and tooth shape 4) Indirect restorations including inlays, onlays and veneers 5) Intraoral repairs of fractured restorations 6) Core build-ups 7) Splinting

Source page: https://510kreport.com/device/K170873
Methodology: https://510kreport.com/methodology