# K012704: Clearfil ST Opaquer

- Pathway: 510(k) (Traditional)
- Applicant: Kuraray Medical, Inc.
- Decided: Sep 10, 2001 after 27 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: 1 generation back to K001913 (2000). 1 ancestor in all.
5 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001913: Clearfil ST Opaquer, Kuraray Company, Ltd. (2000) Summary page 1.

## Most influential descendants
- K063595: Clearfil Majesty Posterior (2007), 4 descendants of its own
- 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
CLEARFIL ST OPAQUER is indicated for the following applications: 1) Masking of metal during intraoral repair of porcelain fused-to-metal crowns. 2) Masking of metal in restoration of post and core crowns. 3) Lightening of stained or discolored teeth in porcelain or composite veneer restorations. 4) Masking of pulp capping materials.

Source page: https://510kreport.com/device/K012704
Methodology: https://510kreport.com/methodology