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FDA 510(k)

G-CEM ONE

K-Number: K200798 · 2020-11-24

ApplicantGC America, Inc.
Decision Date2020-11-24
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

G-CEM ONE is a medical device manufactured by GC America, Inc.. It received FDA 510(k) clearance on 2020-11-24 under approval 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. It is manufactured by GC America, Inc.. The 510(k) number is K200798.

When was G-CEM ONE approved by the FDA?

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

What company makes G-CEM ONE?

G-CEM ONE is manufactured by GC America, Inc..

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

The FDA product code for G-CEM ONE 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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