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FDA 510(k)

Adhese Universal DC, Cention Primer

K-Number: K210804 · 2022-06-07

Decision Date2022-06-07
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Adhese Universal DC, Cention Primer is a medical device manufactured by Ivoclar Vivadent, AG. It received FDA 510(k) clearance on 2022-06-07 under approval number K210804. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Adhese Universal DC, Cention Primer?

Adhese Universal DC, Cention Primer is a medical device that received FDA 510(k) clearance on 2022-06-07. It is manufactured by Ivoclar Vivadent, AG. The 510(k) number is K210804.

When was Adhese Universal DC, Cention Primer approved by the FDA?

Adhese Universal DC, Cention Primer received FDA 510(k) clearance on 2022-06-07, under approval number K210804.

What company makes Adhese Universal DC, Cention Primer?

Adhese Universal DC, Cention Primer is manufactured by Ivoclar Vivadent, AG.

What is the FDA product code for Adhese Universal DC, Cention Primer?

The FDA product code for Adhese Universal DC, Cention Primer is KLE.

Other Devices by Ivoclar Vivadent, AG

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Related Devices (Code: KLE)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.