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FDA 510(k)

VisCalor bulk

K-Number: K190453 · 2019-04-11

ApplicantVoco GmbH
Decision Date2019-04-11
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

VisCalor bulk is the device name listed in this FDA 510(k) record. The listed applicant is Voco GmbH. It received FDA 510(k) clearance on 2019-04-11 under 510(k) number K190453. 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 VisCalor bulk?

VisCalor bulk is a medical device that received FDA 510(k) clearance on 2019-04-11. The listed applicant is Voco GmbH. The 510(k) number is K190453.

When did VisCalor bulk receive FDA 510(k) clearance?

VisCalor bulk received FDA 510(k) clearance on 2019-04-11, under 510(k) number K190453.

Who is the listed applicant for VisCalor bulk?

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 VisCalor bulk?

The FDA product code for VisCalor bulk is EBF.

Other records listing Voco GmbH as applicant

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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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