Futurabond M/Futurabond M Single Dose
FDA 510(k) K082753 · Voco GmbH
510(k) numberK082753
Submission
- Device name
- Futurabond M/Futurabond M Single Dose
- Applicant
- Voco GmbH
Cuxhaven, DE - Received
- September 19, 2008
- Decision date
- November 24, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Futurabond M/Futurabond M Single Dose cleared by the FDA?
Futurabond M/Futurabond M Single Dose (K082753) received a 510(k) decision of Substantially Equivalent on November 24, 2008, 66 days after the submission was received.
What is the product code of K082753?
The FDA product code is KLE – Agent, Tooth Bonding, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3200.