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FDA 510(k)

GC E-LIGHT

K-Number: K012134 · 2001-08-07

ApplicantGC America, Inc.
Decision Date2001-08-07
Product CodeEBZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GC E-LIGHT 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 2001-08-07 under 510(k) number K012134. The device is classified under product code EBZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GC E-LIGHT?

GC E-LIGHT is a medical device that received FDA 510(k) clearance on 2001-08-07. The listed applicant is GC America, Inc.. The 510(k) number is K012134.

When did GC E-LIGHT receive FDA 510(k) clearance?

GC E-LIGHT received FDA 510(k) clearance on 2001-08-07, under 510(k) number K012134.

Who is the listed applicant for GC E-LIGHT?

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 E-LIGHT?

The FDA product code for GC E-LIGHT is EBZ.

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Other records listing GC America, Inc. as applicant

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Related Devices (Code: EBZ)

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.

K253131Curing Light (M-Cure 6)Guangzhou Rebornendo Medical Instrument Co., Ltd.K253461Demi ProMeta Systems Co., Ltd.K242386BluemoonGenoss Co., Ltd.K243921LED Curing Lights (DB686 HALO)Foshan Coxo Medical Instrument Co., Ltd.K250009LED Curing Light (C01-X, C02-X)Premium Plus (Dongguan) LimitedK241238LOOP™ LED Curing Light System (CLK01)Garrison Dental Solutions, LLC

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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