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510(k) Data Aggregation
K Number
K992357Device Name
EASY-CURE (CURING AND WHITENING LIGHT)
Manufacturer
Date Cleared
1999-08-30
(47 days)
Product Code
Regulation Number
872.6070Why did this record match?
Applicant Name (Manufacturer) :
ICS OF NORTH AMERICA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This device is intended for use in:
1. Source of illumination for curing dental restorative materials,
2. Assisting in the whitening process in dental office.
Device Description
The Easy-Cure™ Curing and Whitening Light is comprised of a high-intensity light source filtered and transmitted through an optical fiber for the curing of composite resins and as an aid in the whitening of teeth. The device emits filtered light in the range from 400 to 500 nm. It accepts voltages from 100-230 VAC.
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K Number
K983654Device Name
CYBER-LASE 2000 CURING AND WHITENING LASER
Manufacturer
Date Cleared
1999-01-12
(85 days)
Product Code
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
ICS OF NORTH AMERICA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This device is intended for use in: 1. Source of illumination for curing dental restorative materials, 2. Assisting in the whitening process in dental office.
Device Description
The device is a standard air-cooled argon laser emitting energy at 457 and 502nm. Output energy is less than 450 mW. The delivery system is a fused silica fiber optic system with a stainless steel handpiece. The laser operates on any 120 volt, alternating current, 20 ampere circuit. The unit is about 16" by 10" by 6.7" in dimension and weighs 20 lbs.
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