Orthodontic Flowable Bracket Adhesive
FDA 510(k) K120619 · Novocol, Inc.
510(k) numberK120619
Submission
- Device name
- Orthodontic Flowable Bracket Adhesive
- Applicant
- Novocol, Inc.
Louisville, CO, US - Received
- February 29, 2012
- Decision date
- May 21, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Orthodontic Flowable Bracket Adhesive cleared by the FDA?
Orthodontic Flowable Bracket Adhesive (K120619) received a 510(k) decision of Substantially Equivalent on May 21, 2012, 82 days after the submission was received.
What is the product code of K120619?
The FDA product code is DYH – Adhesive, Bracket And Tooth Conditioner, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3750.