Clearfil Tri-S Bond
FDA 510(k) K042913 · Kuraray Medical, Inc.
510(k) numberK042913
Submission
- Device name
- Clearfil Tri-S Bond
- Applicant
- Kuraray Medical, Inc.
New York, NY, US - Received
- October 21, 2004
- Decision date
- November 26, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Clearfil Tri-S Bond cleared by the FDA?
Clearfil Tri-S Bond (K042913) received a 510(k) decision of Substantially Equivalent on November 26, 2004, 36 days after the submission was received.
What is the product code of K042913?
The FDA product code is KLE – Agent, Tooth Bonding, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3200.