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FDA 510(k)

Provicol QM Aesthetic

K-Number: K201856 · 2020-08-26

ApplicantVoco GmbH
Decision Date2020-08-26
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Provicol QM Aesthetic is the device name listed in this FDA 510(k) record. The listed applicant is Voco GmbH. It received FDA 510(k) clearance on 2020-08-26 under 510(k) number K201856. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Provicol QM Aesthetic?

Provicol QM Aesthetic is a medical device that received FDA 510(k) clearance on 2020-08-26. The listed applicant is Voco GmbH. The 510(k) number is K201856.

When did Provicol QM Aesthetic receive FDA 510(k) clearance?

Provicol QM Aesthetic received FDA 510(k) clearance on 2020-08-26, under 510(k) number K201856.

Who is the listed applicant for Provicol QM Aesthetic?

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

What is the FDA product code for Provicol QM Aesthetic?

The FDA product code for Provicol QM Aesthetic is EMA.

Other records listing Voco GmbH 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: EMA)

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.

K254201Any-CemMediclus Co., Ltd.K261937PacTemp Automix NEThe Belport Company Inc., DBA Gingi-PakK261166DIA-CEMDiaDent Group InternationalK254109G-CEM UNIVERSALGC America, Inc.K253337REGEN Bioactive CementInter-Med, Inc.K252606Bifix Veneer LC, Bifix Veneer Try-InVoco GmbH

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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