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FDA 510(k)

Adhese 2

K-Number: K252450 · 2026-03-05

Decision Date2026-03-05
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Adhese 2 is a medical device manufactured by Ivoclar Vivadent, Inc.. It received FDA 510(k) clearance on 2026-03-05 under approval number K252450. 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 2?

Adhese 2 is a medical device that received FDA 510(k) clearance on 2026-03-05. It is manufactured by Ivoclar Vivadent, Inc.. The 510(k) number is K252450.

When was Adhese 2 approved by the FDA?

Adhese 2 received FDA 510(k) clearance on 2026-03-05, under approval number K252450.

What company makes Adhese 2?

Adhese 2 is manufactured by Ivoclar Vivadent, Inc..

What is the FDA product code for Adhese 2?

The FDA product code for Adhese 2 is KLE.

Other Devices by Ivoclar Vivadent, Inc.

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.