# K191980: CLEARFIL MAJESTY ES Flow

- Pathway: 510(k) (Traditional)
- Applicant: Kuraray Noritake Dental, Inc.
- Decided: Nov 18, 2019 after 117 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K210504: PANAVIA Veneer LC (2021), 0 descendants of its own

## 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. diastema closure, tooth malformation) [4] Intraoral repair of fractured restorations [5] Cementation of ceramic and composite inlays, onlays and veneers with less than 2mm thickness

Source page: https://510kreport.com/device/K191980
Methodology: https://510kreport.com/methodology