# K121583: Clearfil Majesty Flow

- Pathway: 510(k) (Traditional)
- Applicant: Kuraray Noritake Dental, Inc.
- Decided: Jul 25, 2012 after 56 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: 8 generations back to K931812 (1993). 25 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061860: Clearfil Majesty Esthetic, Kuraray Medical, Inc. (2006) Summary page 1.
- K063593: Clearfil Majesty Flow, Kuraray America, Inc. (2007) Summary page 1.

## Most influential descendants
- K182430: Clearfil Majesty IC (2019), 0 descendants of its own
- K170873: Medi Galaxy Flow, Medi Classic, Medi Pearl, Medi Jupiter, Medi Opaque Posterior, Medi White Pearl (2017), 0 descendants of its own
- K130371: Clearfil Majesty ES Flow (2013), 0 descendants of its own

## Indications for use
1) Direct restorations for all cavity classes in anterior and posterior teeth 2) Direct veneers 3) Correction of tooth position and tooth shape (e.g. diastemna closure, dwarfed tooth, etc.) 4) Intraoral repairs of fractured restorations

Source page: https://510kreport.com/device/K121583
Methodology: https://510kreport.com/methodology