Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

BRILLIANT EverGlow Flow

K-Number: K190597 · 2019-06-21

ApplicantColtene/Whaledent AG
Decision Date2019-06-21
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BRILLIANT EverGlow Flow 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 2019-06-21 under 510(k) number K190597. 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 Flow?

BRILLIANT EverGlow Flow is a medical device that received FDA 510(k) clearance on 2019-06-21. The listed applicant is Coltene/Whaledent AG. The 510(k) number is K190597.

When did BRILLIANT EverGlow Flow receive FDA 510(k) clearance?

BRILLIANT EverGlow Flow received FDA 510(k) clearance on 2019-06-21, under 510(k) number K190597.

Who is the listed applicant for BRILLIANT EverGlow Flow?

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 Flow?

The FDA product code for BRILLIANT EverGlow Flow 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 COMPONEERK181500BRILLIANT CriosK160800DuoCemK152927BRILLIANT 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

View on FDA Database →

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

↑