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510(k) Data Aggregation
K Number
K040614Device Name
BLUEWAND LED DENTAL CURING WAND SYSTEM
Manufacturer
Date Cleared
2004-04-07
(29 days)
Product Code
Regulation Number
872.6070Why did this record match?
Applicant Name (Manufacturer) :
J.L. BLOSSER, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The BlueWand™ LED Dental Curing Wand System is a cordless light intended for polymerization of visible light cured materials containing camphorquinone.
Device Description
The BlueWand™ LED Dental Curing Light is a cordless battery-powered unit designed for curing visible light cured (VLC) materials whose initiators are sensitive to light in the 440-480 nm wavelength region of the visible spectrum. The light is based on LED (light emitting diodes) technology for light generation.
The BlueWand™ LED Dental Curing Light System includes:
- Surgical stainless steel handpiece with an LED and control electronics with . rechargeable battery
- Transformer to supply wall power to the base unit ●
- Base unit- charges battery and stores handpiece when not in use .
The BlueWand™ has 6 standard curing modes, consisting of 10, 20 and 30 second durations, and operational from two settings: Manual Setting and Automatic Setting. ("Touch less - ON" function). The Modes are10s, 20s, and 30s, a ramp, and two "30% reduced power" modes for 20s and 30s.
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