FDA 510(k)

G-CEM ONE

K-Number: K200798 · 2020-11-24

Decision Date2020-11-24

Product CodeEMA

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

G-CEM ONE is the device name listed in this FDA 510(k) record. The listed applicant is GC America, Inc.. It received FDA 510(k) clearance on 2020-11-24 under 510(k) number K200798. 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 G-CEM ONE?

G-CEM ONE is a medical device that received FDA 510(k) clearance on 2020-11-24. The listed applicant is GC America, Inc.. The 510(k) number is K200798.

When did G-CEM ONE receive FDA 510(k) clearance?

G-CEM ONE received FDA 510(k) clearance on 2020-11-24, under 510(k) number K200798.

Who is the listed applicant for G-CEM ONE?

The FDA 510(k) record lists GC America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for G-CEM ONE?

The FDA product code for G-CEM ONE is EMA.

Other records listing GC America, Inc. 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)

K254201Any-CemMediclus Co., Ltd.K261937PacTemp Automix NEThe Belport Company Inc., DBA Gingi-Pak K261166DIA-CEMDiaDent Group International K254109G-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.