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FDA 510(k)

ADHESE ONE F

K-Number: K090941 · 2009-07-17

ApplicantIvoclar Vivadent, Inc.
Decision Date2009-07-17
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ADHESE ONE F 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 2009-07-17 under 510(k) number K090941. 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 ONE F?

ADHESE ONE F is a medical device that received FDA 510(k) clearance on 2009-07-17. The listed applicant is Ivoclar Vivadent, Inc.. The 510(k) number is K090941.

When did ADHESE ONE F receive FDA 510(k) clearance?

ADHESE ONE F received FDA 510(k) clearance on 2009-07-17, under 510(k) number K090941.

Who is the listed applicant for ADHESE ONE F?

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 ONE F?

The FDA product code for ADHESE ONE F 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.

K262252MPa Max adhesiveDen-Mat Holdings, LLCK260485Any-EtchMediclus Co., Ltd.K260430Porcelain Etch GelBelport Company, Inc., Gingi-PakK252450Adhese 2Ivoclar Vivadent, Inc.K260682Bond-PR™ Universal AdhesivePremier Dental Products CompanyK251587VITA VMLC PrimerVita Zahnfabrik H. Rauter GmbH & Co. Kg.

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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