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FDA 510(k)

GC ELITE CEMENT

K-Number: K935521 · 1994-01-06

ApplicantGC America, Inc.
Decision Date1994-01-06
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GC ELITE CEMENT 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 1994-01-06 under 510(k) number K935521. 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 ELITE CEMENT?

GC ELITE CEMENT is a medical device that received FDA 510(k) clearance on 1994-01-06. The listed applicant is GC America, Inc.. The 510(k) number is K935521.

When did GC ELITE CEMENT receive FDA 510(k) clearance?

GC ELITE CEMENT received FDA 510(k) clearance on 1994-01-06, under 510(k) number K935521.

Who is the listed applicant for GC ELITE CEMENT?

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 ELITE CEMENT?

The FDA product code for GC ELITE CEMENT is EMA.

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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.

K262202Cerasmart ForteK253317Cytrans™ ElashieldK261246SRGC-06K254109G-CEM UNIVERSALK251124G-Bond UniversalK250953EQUIA LC ONE

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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.

K262983EsTemp ImplantSpident Co., Ltd.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.

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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