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FDA 510(k)

GC Fuji Triage EP

K-Number: K193484 · 2020-07-02

ApplicantGC America, Inc.
Decision Date2020-07-02
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GC Fuji Triage EP is a medical device manufactured by GC America, Inc.. It received FDA 510(k) clearance on 2020-07-02 under approval number K193484. 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 Triage EP?

GC Fuji Triage EP is a medical device that received FDA 510(k) clearance on 2020-07-02. It is manufactured by GC America, Inc.. The 510(k) number is K193484.

When was GC Fuji Triage EP approved by the FDA?

GC Fuji Triage EP received FDA 510(k) clearance on 2020-07-02, under approval number K193484.

What company makes GC Fuji Triage EP?

GC Fuji Triage EP is manufactured by GC America, Inc..

What is the FDA product code for GC Fuji Triage EP?

The FDA product code for GC Fuji Triage EP is EMA.

Other Devices by GC America, Inc.

K153130Initial LiSi Block K153325Gradia Plus K153231G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi Primer K153136Initial LiSi Press K153127everX Posterior K152274MSCB-001

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Related Devices (Code: EMA)

K160800DuoCemColtene/Whaledent AG K161851Glass Ionomer Cement (Luting)Shandong Huge Dental Material Corporation K160443TempoCem ClearDmg USA, Inc. K160774IonoStar PlusVoco GmbH K161256TheraCemBisco, Inc. K153231G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi PrimerGC America, Inc.

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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