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FDA 510(k)

BRILLIANT Crios

K-Number: K181500 · 2018-08-15

ApplicantColtene/Whaledent AG
Decision Date2018-08-15
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BRILLIANT Crios 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 2018-08-15 under 510(k) number K181500. 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 Crios?

BRILLIANT Crios is a medical device that received FDA 510(k) clearance on 2018-08-15. The listed applicant is Coltene/Whaledent AG. The 510(k) number is K181500.

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

BRILLIANT Crios received FDA 510(k) clearance on 2018-08-15, under 510(k) number K181500.

Who is the listed applicant for BRILLIANT Crios?

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 Crios?

The FDA product code for BRILLIANT Crios 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 FlowK160800DuoCemK152927BRILLIANT EVERGLOW

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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