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FDA 510(k)

TEMPORARY C&B COMPOSITE

K-Number: K091894 · 2009-07-23

ApplicantVoco GmbH
Decision Date2009-07-23
Product CodeEBG
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TEMPORARY C&B COMPOSITE is the device name listed in this FDA 510(k) record. The listed applicant is Voco GmbH. It received FDA 510(k) clearance on 2009-07-23 under 510(k) number K091894. The device is classified under product code EBG. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TEMPORARY C&B COMPOSITE?

TEMPORARY C&B COMPOSITE is a medical device that received FDA 510(k) clearance on 2009-07-23. The listed applicant is Voco GmbH. The 510(k) number is K091894.

When did TEMPORARY C&B COMPOSITE receive FDA 510(k) clearance?

TEMPORARY C&B COMPOSITE received FDA 510(k) clearance on 2009-07-23, under 510(k) number K091894.

Who is the listed applicant for TEMPORARY C&B COMPOSITE?

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 TEMPORARY C&B COMPOSITE?

The FDA product code for TEMPORARY C&B COMPOSITE is EBG.

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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: EBG)

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.

K261261Dura-ArchHangzhou SHINING3D Dental Technology Co., Ltd.K253380“FLNT Base” and “FLNT Temp”Liaoning Upcera Co., Ltd.K251271TempFIT Temporary Crown and Bridge ResinRizhao Huge Biomaterials Company, Ltd.K243370DentaTOOTHAsiga Pty, Ltd.K243621Evoblock, PerléonEvoden Indústria Comércio Importação E ExportaçãoK243951TEMP MASTER, PMMA-based dental resinTaiwan Dental Materials 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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