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FDA 510(k)

Opallis, Opallis Flow

K-Number: K201707 · 2020-12-22

ApplicantDentscare Ltda
Decision Date2020-12-22
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Opallis, Opallis Flow is the device name listed in this FDA 510(k) record. The listed applicant is Dentscare Ltda. It received FDA 510(k) clearance on 2020-12-22 under 510(k) number K201707. 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 Opallis, Opallis Flow?

Opallis, Opallis Flow is a medical device that received FDA 510(k) clearance on 2020-12-22. The listed applicant is Dentscare Ltda. The 510(k) number is K201707.

When did Opallis, Opallis Flow receive FDA 510(k) clearance?

Opallis, Opallis Flow received FDA 510(k) clearance on 2020-12-22, under 510(k) number K201707.

Who is the listed applicant for Opallis, Opallis Flow?

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

What is the FDA product code for Opallis, Opallis Flow?

The FDA product code for Opallis, Opallis Flow is EBF.

Other records listing Dentscare Ltda 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.

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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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