# K063593: Clearfil Majesty Flow

- Pathway: 510(k) (Traditional)
- Applicant: Kuraray America, Inc.
- Decided: Feb 2, 2007 after 60 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: 7 generations back to K931812 (1993). 21 ancestors in all.
17 later devices descend from it; 5 cite it directly.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993783: Tetric Flow, Ivoclar North America, Inc. (1999) Summary page 1.
- K012740: Clearfil AP-X, Kuraray Medical, Inc. (2001) Summary page 1.
- K033267: Epricord, Kuraray Medical, Inc. (2003) Summary page 1.
- K012442: Modification to Clearfil SE Bond, Kuraray Medical, Inc. (2001) Summary page 1.

## Most influential descendants
- K111982: Clearfil DC Core Plus (2011), 6 descendants of its own
- K142625: PANAVIA SA Cement Plus Automix; (Universal (A2), White, Translucent); Value Pack (Universal (A2), Translucent); Automix Trial (Universal (A2), White, Translucent); Mixing tip; Endo tip (SS) (2015), 4 descendants of its own
- K111980: Clearfil Tri-S Bond Plus (2011), 4 descendants of its own
- K121583: Clearfil Majesty Flow (2012), 3 descendants of its own
- K150704: PANAVIA V5: Standard Kit (Universal (A2)), Standard Kit (Clear), Introductory Kit (Universal (A2)), Introductory Kit (Clear), Sample Pack (Universal (A2)), Paste (Universal (A2)), Paste (Clear), Paste (Brown (A4)), Paste (White), Paste (Opaque), Try-in Paste (Universal (A2)), Try-in Paste (Clear), Try-in Paste (Brown (A4)), Try-in Paste (White), Try-in Paste (Opaque), Tooth Primer (2015), 2 descendants of its own

## Indications for use
CLEARFIL MAJESTY Flow is indicated for the following restorative applications: - Direct restorations for anterior and posterior teeth (Class I - III, V cavities, cervical caries, root erosion) - Cavity base / liner - Intraoral repairs of fractured crowns / bridges / composite resin

Source page: https://510kreport.com/device/K063593
Methodology: https://510kreport.com/methodology