Transbond Supreme Adhesive
FDA 510(k) K073697 · 3M Unitek
510(k) numberK073697
Submission
- Device name
- Transbond Supreme Adhesive
- Applicant
- 3M Unitek
Monrovia, CA, US - Received
- December 31, 2007
- Decision date
- February 15, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Transbond Supreme Adhesive cleared by the FDA?
Transbond Supreme Adhesive (K073697) received a 510(k) decision of Substantially Equivalent on February 15, 2008, 46 days after the submission was received.
What is the product code of K073697?
The FDA product code is DYH – Adhesive, Bracket And Tooth Conditioner, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3750.