Clearfil Tri-S Bond Plus Single Dose Standard / Value / Introductory Pack

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K111975 ↗

FDA Product Code

KLE

Device Class

Class II

Regulation

21 CFR Part 872.3200

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Clearfil Photo Core

  Class II

  FDA 510(k) K012705 Active Cleared 11 Sep 2001

• Clearfil Ceramic Primer

  Class II

  FDA 510(k) K061906 Active Cleared 28 Sep 2006

• Clearfil Ap-X

  Class II

  FDA 510(k) K012740 Active Cleared 14 Sep 2001

• Clearfil Photo Core Plt

  Class II

  FDA 510(k) K033970 Active Cleared 26 Mar 2004

• Clearfil Ap-X Plt Intro Kit

  Class II

  FDA 510(k) K022999 Active Cleared 24 Oct 2002

• Clearfil Majety Posterior

  Class II

  FDA 510(k) K100328 Active Cleared 5 Mar 2010

See all devices from Kuraray Medical, Inc. →