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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Ivoclar Vivadent, Inc.. It received FDA 510(k) clearance on 2026-03-05 under 510(k) 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. The listed applicant is Ivoclar Vivadent, Inc.. The 510(k) number is K252450.

When did Adhese 2 receive FDA 510(k) clearance?

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

Who is the listed applicant for Adhese 2?

The FDA 510(k) record lists Ivoclar Vivadent, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Adhese 2?

The FDA product code for Adhese 2 is KLE.

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Other records listing Ivoclar Vivadent, Inc. as applicant

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Related Devices (Code: KLE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260485Any-EtchMediclus Co., Ltd.K260430Porcelain Etch GelBelport Company, Inc., Gingi-PakK260682Bond-PR™ Universal AdhesivePremier Dental Products CompanyK251587VITA VMLC PrimerVita Zahnfabrik H. Rauter GmbH & Co. Kg.K252151els unibondSaremco Dental AGK252469MAGNABOND SE; MAGNABOND UNIVERSAL; MAGNABOND UNIVERSAL DCADmp Dental Industry S.A.

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.

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