# K063595: Clearfil Majesty Posterior

- Pathway: 510(k) (Traditional)
- Applicant: Kuraray America, Inc.
- Decided: Feb 9, 2007 after 67 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). 52 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 57 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.
- K012740: Clearfil AP-X, Kuraray Medical, Inc. (2001) Summary page 1.
- K042929: Estenia C&B, Kuraray Medical Kurashiki Plant (2004) Summary page 1.
- K943170: Clearfil Liner Bond 2, Kuraray Company, Ltd. (1994) Summary page 1.
- K993783: Tetric Flow, Ivoclar North America, Inc. (1999) Summary page 1.
- K012442: Modification to Clearfil SE Bond, Kuraray Medical, Inc. (2001) Summary page 2.
- K012704: Clearfil ST Opaquer, Kuraray Medical, Inc. (2001) Summary page 2.

## Most influential descendants
- K071169: Clearfil Majesty Posterior PLT (2007), 1 descendant of its own
- K162967: nuance UNIVERSAL (2017), 0 descendants of its own
- K100328: Clearfil Majety Posterior (2010), 0 descendants of its own
- K092281: Clearfil Majesty Posterior PLT (2009), 0 descendants of its own

## Indications for use
1) Direct restorations for anterior and posterior teeth (Class I - V cavities) 2) Correction of tooth position and tooth shape (e.g. diastema closure, dwarfed tooth, etc.) 3) Intraoral repairs of fractured crowns/bridges

Source page: https://510kreport.com/device/K063595
Methodology: https://510kreport.com/methodology