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FDA 510(k)

Admira Fusion x-base

K-Number: K170896 · 2017-06-29

ApplicantVoco GmbH
Decision Date2017-06-29
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Admira Fusion x-base is the device name listed in this FDA 510(k) record. The listed applicant is Voco GmbH. It received FDA 510(k) clearance on 2017-06-29 under 510(k) number K170896. 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 x-base?

Admira Fusion x-base is a medical device that received FDA 510(k) clearance on 2017-06-29. The listed applicant is Voco GmbH. The 510(k) number is K170896.

When did Admira Fusion x-base receive FDA 510(k) clearance?

Admira Fusion x-base received FDA 510(k) clearance on 2017-06-29, under 510(k) number K170896.

Who is the listed applicant for Admira Fusion x-base?

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 x-base?

The FDA product code for Admira Fusion x-base 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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