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FDA 510(k)

RAPICURE 200 (CURING AND WHITENING LIGHT)

K-Number: K993223 · 1999-11-01

ApplicantMediphotonix, LC
Decision Date1999-11-01
Product CodeEBZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

RAPICURE 200 (CURING AND WHITENING LIGHT) is the device name listed in this FDA 510(k) record. The listed applicant is Mediphotonix, LC. It received FDA 510(k) clearance on 1999-11-01 under 510(k) number K993223. 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 RAPICURE 200 (CURING AND WHITENING LIGHT)?

RAPICURE 200 (CURING AND WHITENING LIGHT) is a medical device that received FDA 510(k) clearance on 1999-11-01. The listed applicant is Mediphotonix, LC. The 510(k) number is K993223.

When did RAPICURE 200 (CURING AND WHITENING LIGHT) receive FDA 510(k) clearance?

RAPICURE 200 (CURING AND WHITENING LIGHT) received FDA 510(k) clearance on 1999-11-01, under 510(k) number K993223.

Who is the listed applicant for RAPICURE 200 (CURING AND WHITENING LIGHT)?

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

What is the FDA product code for RAPICURE 200 (CURING AND WHITENING LIGHT)?

The FDA product code for RAPICURE 200 (CURING AND WHITENING LIGHT) is EBZ.

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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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