Dentoetch Quickbond Bond Activator
FDA 510(k) K122522 · Itena Clinical
510(k) numberK122522
Submission
- Device name
- Dentoetch Quickbond Bond Activator
- Applicant
- Itena Clinical
Laval, CA - Received
- August 20, 2012
- Decision date
- March 19, 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 Dentoetch Quickbond Bond Activator cleared by the FDA?
Dentoetch Quickbond Bond Activator (K122522) received a 510(k) decision of Substantially Equivalent on March 19, 2013, 211 days after the submission was received.
What is the product code of K122522?
The FDA product code is KLE – Agent, Tooth Bonding, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3200.