Clearfil Se Bond 2 Kit; Clearfil Se Bond 2 Value Pack; Clearfil Se Bond 2 Trial Pack; Clearfil Se Bond 2 Bond; Clearfil
FDA 510(k) K131432 · Kuraray Noritake Dental, Inc.
510(k) numberK131432
Submission
- Device name
- Clearfil Se Bond 2 Kit; Clearfil Se Bond 2 Value Pack; Clearfil Se Bond 2 Trial Pack; Clearfil Se Bond 2 Bond; Clearfil
- Applicant
- Kuraray Noritake Dental, Inc.
Chiyoda-Ku, JP - Received
- May 17, 2013
- Decision date
- August 22, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Clearfil Se Bond 2 Kit; Clearfil Se Bond 2 Value Pack; Clearfil Se Bond 2 Trial Pack; Clearfil Se Bond 2 Bond; Clearfil cleared by the FDA?
Clearfil Se Bond 2 Kit; Clearfil Se Bond 2 Value Pack; Clearfil Se Bond 2 Trial Pack; Clearfil Se Bond 2 Bond; Clearfil (K131432) received a 510(k) decision of Substantially Equivalent on August 22, 2013, 97 days after the submission was received.
What is the product code of K131432?
The FDA product code is KLE – Agent, Tooth Bonding, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3200.