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FDA 510(k)

Adhese Universal DC, Cention Primer

K-Number: K210804 · 2022-06-07

ApplicantIvoclar Vivadent, AG
Decision Date2022-06-07
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Adhese Universal DC, Cention Primer is the device name listed in this FDA 510(k) record. The listed applicant is Ivoclar Vivadent, AG. It received FDA 510(k) clearance on 2022-06-07 under 510(k) 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. The listed applicant is Ivoclar Vivadent, AG. The 510(k) number is K210804.

When did Adhese Universal DC, Cention Primer receive FDA 510(k) clearance?

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

Who is the listed applicant for Adhese Universal DC, Cention Primer?

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

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

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

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Other records listing Ivoclar Vivadent, AG 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-PakK252450Adhese 2Ivoclar Vivadent, Inc.K260682Bond-PR™ Universal AdhesivePremier Dental Products CompanyK251587VITA VMLC PrimerVita Zahnfabrik H. Rauter GmbH & Co. Kg.K252151els unibondSaremco Dental AG

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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