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FDA 510(k)

GC FujiCEM 2 (Improved)

K-Number: K182854 · 2019-07-11

ApplicantGC America, Inc.
Decision Date2019-07-11
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GC FujiCEM 2 (Improved) 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 2019-07-11 under 510(k) number K182854. 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 GC FujiCEM 2 (Improved)?

GC FujiCEM 2 (Improved) is a medical device that received FDA 510(k) clearance on 2019-07-11. The listed applicant is GC America, Inc.. The 510(k) number is K182854.

When did GC FujiCEM 2 (Improved) receive FDA 510(k) clearance?

GC FujiCEM 2 (Improved) received FDA 510(k) clearance on 2019-07-11, under 510(k) number K182854.

Who is the listed applicant for GC FujiCEM 2 (Improved)?

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 GC FujiCEM 2 (Improved)?

The FDA product code for GC FujiCEM 2 (Improved) 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)

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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