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FDA 510(k)

Vittra APS Unique

K-Number: K210231 · 2021-10-14

ApplicantDentscare Ltda
Decision Date2021-10-14
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Vittra APS Unique is the device name listed in this FDA 510(k) record. The listed applicant is Dentscare Ltda. It received FDA 510(k) clearance on 2021-10-14 under 510(k) number K210231. 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 Vittra APS Unique?

Vittra APS Unique is a medical device that received FDA 510(k) clearance on 2021-10-14. The listed applicant is Dentscare Ltda. The 510(k) number is K210231.

When did Vittra APS Unique receive FDA 510(k) clearance?

Vittra APS Unique received FDA 510(k) clearance on 2021-10-14, under 510(k) number K210231.

Who is the listed applicant for Vittra APS Unique?

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 Vittra APS Unique?

The FDA product code for Vittra APS Unique 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.

K231859PrimmaArtK232994Vittra APS Unique FlowK201707Opallis, Opallis FlowK192682Orthocem, Ortho BiteK191389Allcem Veneer APSK191306Llis, Vittra APS

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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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