FDA 510(k)

GC Fuji Direct

K-Number: K172382 · 2018-04-02

Decision Date2018-04-02

Product CodeEMA

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

GC Fuji Direct 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 2018-04-02 under 510(k) number K172382. 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 Direct?

GC Fuji Direct is a medical device that received FDA 510(k) clearance on 2018-04-02. The listed applicant is GC America, Inc.. The 510(k) number is K172382.

When did GC Fuji Direct receive FDA 510(k) clearance?

GC Fuji Direct received FDA 510(k) clearance on 2018-04-02, under 510(k) number K172382.

Who is the listed applicant for GC Fuji Direct?

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 Direct?

The FDA product code for GC Fuji Direct 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.

K253317Cytrans™ Elashield K261246SRGC-06 K254109G-CEM UNIVERSAL K251124G-Bond Universal K250953EQUIA LC ONE K251946G aenial Universal Injectable II

View all 24 devices →

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.