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FDA 510(k)

Admira Fusion Flow

K-Number: K153177 · 2016-06-30

ApplicantVoco GmbH
Decision Date2016-06-30
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Admira Fusion Flow is the device name listed in this FDA 510(k) record. The listed applicant is Voco GmbH. It received FDA 510(k) clearance on 2016-06-30 under 510(k) number K153177. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Admira Fusion Flow?

Admira Fusion Flow is a medical device that received FDA 510(k) clearance on 2016-06-30. The listed applicant is Voco GmbH. The 510(k) number is K153177.

When did Admira Fusion Flow receive FDA 510(k) clearance?

Admira Fusion Flow received FDA 510(k) clearance on 2016-06-30, under 510(k) number K153177.

Who is the listed applicant for Admira Fusion Flow?

The FDA 510(k) record lists Voco GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Admira Fusion Flow?

The FDA product code for Admira Fusion Flow is EBF.

Other records listing Voco GmbH as applicant

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.

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Related Devices (Code: EBF)

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.

K262228Transcend Bulk Fill Flowable CompositeUltradent Products, Inc.K261485Tetric plus Fill;Tetric plus FlowIvoclar Vivadent, Inc.K261246SRGC-06GC America, Inc.K261093DIAFILDiaDent Group InternationalK261071DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g)DiaDent Group InternationalK260805Dual CoreVericom Co., Ltd.

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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