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FDA 510(k)

Omnichroma Flow Bulk

K-Number: K203598 · 2021-02-03

ApplicantTokuyama Dental Corporation
Decision Date2021-02-03
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Omnichroma Flow Bulk is the device name listed in this FDA 510(k) record. The listed applicant is Tokuyama Dental Corporation. It received FDA 510(k) clearance on 2021-02-03 under 510(k) number K203598. 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 Omnichroma Flow Bulk?

Omnichroma Flow Bulk is a medical device that received FDA 510(k) clearance on 2021-02-03. The listed applicant is Tokuyama Dental Corporation. The 510(k) number is K203598.

When did Omnichroma Flow Bulk receive FDA 510(k) clearance?

Omnichroma Flow Bulk received FDA 510(k) clearance on 2021-02-03, under 510(k) number K203598.

Who is the listed applicant for Omnichroma Flow Bulk?

The FDA 510(k) record lists Tokuyama Dental Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Omnichroma Flow Bulk?

The FDA product code for Omnichroma Flow Bulk is EBF.

Other records listing Tokuyama Dental Corporation 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.

K203760Tokuyama Universal Bond IIK193537Omnichroma FlowK190940Tokuyama Rebase IIIK180613Estelite Universal FlowK173275OMNICHROMAK171226TOKUYAMA UNIVERSAL BOND

View all 9 devices →

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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