Adhese Universal DC, Cention Primer
FDA 510(k) K210804 · Ivoclar Vivadent, AG
510(k) numberK210804
Submission
- Device name
- Adhese Universal DC, Cention Primer
- Applicant
- Ivoclar Vivadent, AG
Schaan, LI - Received
- March 17, 2021
- Decision date
- June 7, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Adhese Universal DC, Cention Primer cleared by the FDA?
Adhese Universal DC, Cention Primer (K210804) received a 510(k) decision of Substantially Equivalent on June 7, 2022, 447 days after the submission was received.
What is the product code of K210804?
The FDA product code is KLE – Agent, Tooth Bonding, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3200.