# K061860: Clearfil Majesty Esthetic

- Pathway: 510(k) (Traditional)
- Applicant: Kuraray Medical, Inc.
- Decided: Sep 18, 2006 after 80 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: 2 generations back to K943168 (1994). 5 ancestors in all.
11 later devices descend from it; 4 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012740: Clearfil AP-X, Kuraray Medical, Inc. (2001) Summary page 1.
- K033267: Epricord, Kuraray Medical, Inc. (2003) Summary page 1.
- K023814: Gradia Direct, GC America, Inc. (2003) Summary page 1.
- K042819: Tetric Evoceram, Ivoclar Vivadent, Inc. (2004) Summary page 1.

## Most influential descendants
- K063595: Clearfil Majesty Posterior (2007), 4 descendants of its own
- K121583: Clearfil Majesty Flow (2012), 3 descendants of its own
- K071169: Clearfil Majesty Posterior PLT (2007), 1 descendant of its own
- K192178: R&D Series Nova Compo N (2019), 0 descendants of its own
- K182430: Clearfil Majesty IC (2019), 0 descendants of its own

## Indications for use
1) Direct restorations for anterior and posterior teeth (Class I - V cavities) 2) Direct veneers 3) Correction of tooth position and tooth shape (e.g. diastema closure, dwarfed tooth, etc.) 4) Intraoral repairs of fractured crowns/bridges

Source page: https://510kreport.com/device/K061860
Methodology: https://510kreport.com/methodology