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FDA 510(k)

BRILLIANT EVERGLOW

K-Number: K152927 · 2016-04-28

ApplicantColtene/Whaledent AG
Decision Date2016-04-28
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BRILLIANT EVERGLOW is the device name listed in this FDA 510(k) record. The listed applicant is Coltene/Whaledent AG. It received FDA 510(k) clearance on 2016-04-28 under 510(k) number K152927. 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 BRILLIANT EVERGLOW?

BRILLIANT EVERGLOW is a medical device that received FDA 510(k) clearance on 2016-04-28. The listed applicant is Coltene/Whaledent AG. The 510(k) number is K152927.

When did BRILLIANT EVERGLOW receive FDA 510(k) clearance?

BRILLIANT EVERGLOW received FDA 510(k) clearance on 2016-04-28, under 510(k) number K152927.

Who is the listed applicant for BRILLIANT EVERGLOW?

The FDA 510(k) record lists Coltene/Whaledent AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BRILLIANT EVERGLOW?

The FDA product code for BRILLIANT EVERGLOW is EBF.

Other records listing Coltene/Whaledent AG 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.

K191385BRILLIANT COMPONEERK190597BRILLIANT EverGlow FlowK181500BRILLIANT CriosK160800DuoCem

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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