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FDA 510(k)

HELIOLUX VISIBLE CURING LIGHT

K-Number: K901908 · 1990-07-13

ApplicantIvoclar North America, Inc.
Decision Date1990-07-13
Product CodeEBZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

HELIOLUX VISIBLE CURING LIGHT is the device name listed in this FDA 510(k) record. The listed applicant is Ivoclar North America, Inc.. It received FDA 510(k) clearance on 1990-07-13 under 510(k) number K901908. 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 HELIOLUX VISIBLE CURING LIGHT?

HELIOLUX VISIBLE CURING LIGHT is a medical device that received FDA 510(k) clearance on 1990-07-13. The listed applicant is Ivoclar North America, Inc.. The 510(k) number is K901908.

When did HELIOLUX VISIBLE CURING LIGHT receive FDA 510(k) clearance?

HELIOLUX VISIBLE CURING LIGHT received FDA 510(k) clearance on 1990-07-13, under 510(k) number K901908.

Who is the listed applicant for HELIOLUX VISIBLE CURING LIGHT?

The FDA 510(k) record lists Ivoclar North America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HELIOLUX VISIBLE CURING LIGHT?

The FDA product code for HELIOLUX VISIBLE CURING LIGHT is EBZ.

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Other records listing Ivoclar North 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.

K012174ERIS LAYERING MATERIALSK011491HELIOSEAL CLEAR CHROMAK011492IN TEN-SK011490MODIFICATION TO EXCITEK011023D.SIGN 96K011022BIOUNIVERSAL PDF

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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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