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FDA 510(k)

REMECURE MODEL CL 15E

K-Number: K023652 · 2003-01-09

ApplicantRemedent NV
Decision Date2003-01-09
Product CodeEBZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

REMECURE MODEL CL 15E is the device name listed in this FDA 510(k) record. The listed applicant is Remedent NV. It received FDA 510(k) clearance on 2003-01-09 under 510(k) number K023652. 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 REMECURE MODEL CL 15E?

REMECURE MODEL CL 15E is a medical device that received FDA 510(k) clearance on 2003-01-09. The listed applicant is Remedent NV. The 510(k) number is K023652.

When did REMECURE MODEL CL 15E receive FDA 510(k) clearance?

REMECURE MODEL CL 15E received FDA 510(k) clearance on 2003-01-09, under 510(k) number K023652.

Who is the listed applicant for REMECURE MODEL CL 15E?

The FDA 510(k) record lists Remedent NV as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REMECURE MODEL CL 15E?

The FDA product code for REMECURE MODEL CL 15E is EBZ.

Related Clinical Trials

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.

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Other records listing Remedent NV 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.

K082594REMESENSE

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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