Adhese 2
K-Number: K252450 · 2026-03-05
ApplicantIvoclar Vivadent, Inc.
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.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.