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FDA 510(k)

Bifix Hybrid Abutment Cement

K-Number: K220640 · 2022-08-23

ApplicantVoco GmbH
Decision Date2022-08-23
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Bifix Hybrid Abutment Cement is the device name listed in this FDA 510(k) record. The listed applicant is Voco GmbH. It received FDA 510(k) clearance on 2022-08-23 under 510(k) number K220640. 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 Bifix Hybrid Abutment Cement?

Bifix Hybrid Abutment Cement is a medical device that received FDA 510(k) clearance on 2022-08-23. The listed applicant is Voco GmbH. The 510(k) number is K220640.

When did Bifix Hybrid Abutment Cement receive FDA 510(k) clearance?

Bifix Hybrid Abutment Cement received FDA 510(k) clearance on 2022-08-23, under 510(k) number K220640.

Who is the listed applicant for Bifix Hybrid Abutment Cement?

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 Bifix Hybrid Abutment Cement?

The FDA product code for Bifix Hybrid Abutment Cement 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.

K252073VOCO Profluorid Varnish + BioMinK261357Grandio disc multicolorK252606Bifix Veneer LC, Bifix Veneer Try-InK251390MTA vptK251239GrandioSO UnlimitedK231817AlignerFlow LC

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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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