# K130371: Clearfil Majesty ES Flow

- Pathway: 510(k) (Traditional)
- Applicant: Kuraray Noritake Dental, Inc.
- Decided: Apr 9, 2013 after 54 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)
- K063593: Clearfil Majesty Flow, Kuraray America, Inc. (2007) Summary page 1.
- K121583: Clearfil Majesty Flow, Kuraray Noritake Dental, Inc. (2012) Summary page 1.

## Indications for use
CLEARFIL MAJESTY ES Flow is indicated for the following restorative applications: [1] Direct restorations for all cavity classes, cervical lesions (e.g. root surface caries, v-shape defects), tooth wear, and tooth erosion [2] Cavity base / liner [3] Correction of tooth position and tooth shape (e.g. diastem closure, tooth malformation) [4] Intraoral repair of fractured restorations

Source page: https://510kreport.com/device/K130371
Methodology: https://510kreport.com/methodology