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510(k) Data Aggregation
K Number
K033697Device Name
POWER LED
Manufacturer
Date Cleared
2004-02-27
(94 days)
Product Code
Regulation Number
872.6070Why did this record match?
Applicant Name (Manufacturer) :
DENTAL PRODUCTS OF USA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The intended use of Power LED is to act as a polymerization source using visible light to cure composite resins.
Device Description
The Power LED Cordless Curing Light is a device used for the polymerization of dental materials using visible light. It consists of a cordless LED curing handpiece, a battery charger and a remote handpiece holder. The plastic molded handpiece will contain a detachable rechargeable battery pack, an LED light "engine". A printed circuit board with a digital circuit will be utilized to control four different curing modes. Each mode specifies LED timing and audible beep timing. A segmented display will depict the curing modes. A separate pushbutton will activate the light. The molded plastic battery charger will have a single well for charging the battery pack, and Indictor lights to indicate battery charge status.
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