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510(k) Data Aggregation
K Number
K051545Device Name
L.E. DEMETRON II
Manufacturer
KERR CORPORATION (DANBURY)
Date Cleared
2005-07-18
(38 days)
Product Code
EBZ
Regulation Number
872.6070Why did this record match?
Applicant Name (Manufacturer) :
KERR CORPORATION (DANBURY)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The L.E.Demetron II is an L.E.D. visible light curing unit intended for polymerization of light cure materials by dental professionals.
Device Description
The L.E.Demetron II 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 pack, a battery charger with built-in radiometer and a remote handpiece holder. The plastic molded handpiece contains an LED light source, a cooling fan and a digital electronic circuit consisting of surface mount components mounted on circuit boards. The handpiece functions, LED online cooling fan, display output, curing mode selection and low battery indicators, are controlled by the digital electronic circuit and a Complex Programmable Logic Device (CPLD) chiponionous of C into the control circuitry. The handpiece has a mode select button for activating the hondpoiece and selecting the desired curing mode. A second "trigger" button is used to activate the LED output. The handpiece is powered by a removable 4 cell, low voltage, Ni-MH battery pack. 22 volded plastic, triangular enclosure houses a printed circuit board with control circuitry for the battery charging function and the LED curing radiometer.
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K Number
K020091Device Name
OPTILUX 501
Manufacturer
KERR CORPORATION (DANBURY)
Date Cleared
2002-03-21
(70 days)
Product Code
EBZ
Regulation Number
872.6070Why did this record match?
Applicant Name (Manufacturer) :
KERR CORPORATION (DANBURY)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Optilux 501 is a visible curing unit intended for polymerization of light cure materials and activation of dental bleaching materials.
Device Description
The Optilux 501 is a device used for the polymerization of dental materials using visible light. It consists of a control unit and cord connected hand piece. The molded plastic control unit contains a power inlet receptacle for a detachable mains power cord, fuse holders and fuses, mains wiring, mains supply isolation transformer, printed circuit board with control circuitry for lamp and cooling fan functions and an integrated curing radiometer. The cord connected molded plastic hand piece contains a low voltage halogen lamp, optical filter assembly and fiber optic light guide that generates visible (blue-white) light energy having the wavelength range of approximately 400nm -505 nm. The hand piece also contains a small printed circuit board with a micro-switch for activation of the curing lamp.
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