Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal
FDA 510(k) K231696 · Prevest Denpro Limited
510(k) numberK231696
Submission
- Device name
- Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal
- Applicant
- Prevest Denpro Limited
Bari Brahmana, IN - Received
- June 12, 2023
- Decision date
- August 11, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal cleared by the FDA?
Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal (K231696) received a 510(k) decision of Substantially Equivalent on August 11, 2023, 60 days after the submission was received.
What is the product code of K231696?
The FDA product code is KLE – Agent, Tooth Bonding, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3200.