FDA 510(k)

GC FUJI TEMP

K-Number: K101420 · 2010-09-17

Decision Date2010-09-17

Product CodeEMA

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

GC FUJI TEMP 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 2010-09-17 under 510(k) number K101420. 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 FUJI TEMP?

GC FUJI TEMP is a medical device that received FDA 510(k) clearance on 2010-09-17. The listed applicant is GC America, Inc.. The 510(k) number is K101420.

When did GC FUJI TEMP receive FDA 510(k) clearance?

GC FUJI TEMP received FDA 510(k) clearance on 2010-09-17, under 510(k) number K101420.

Who is the listed applicant for GC FUJI TEMP?

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 FUJI TEMP?

The FDA product code for GC FUJI TEMP 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)

K262983EsTemp ImplantSpident Co., Ltd.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.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.