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510(k) Data Aggregation
K Number
K070373Device Name
APOZA LED CURING LIGHT, MODEL E-MORLIT, D-2000, TOP 3W, TOP 5W
Manufacturer
APOZA ENTERPRISE CO. LTD.
Date Cleared
2007-03-02
(22 days)
Product Code
EBZ
Regulation Number
872.6070Why did this record match?
Applicant Name (Manufacturer) :
APOZA ENTERPRISE CO. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The APOZA LED Curing Light is a dental curing light that is designed for use in the optical polymerization of dental resins.
Device Description
APOZA LED Curing Light (Family: Model# E-Morl.it , D-2000 , TOP 3W, TOP 5W) is non-invasive medical device and is designed for use in the optical polymerization of dental resins. APOZA LED Curiing Light deliver 440-490nm blue light. APOZA LED Curing Light is also called APOZA Dental Curing Light. it includes the following models: . E-MorLit consist of a rechargeable Li-ion Battery (DC3.7V ; 2350mAH) in the handy unit and a switching power adaptor (also used as battery charger) , () D-2000 consist of a rechargeable Li-ion Battery (DC3.7V ; 2350mAH) in the handy unit and a switching power adaptor (also used as battery charger) () TOP 3W consist of a handy unit and a switching power adaptor. () TOP 5W consist of a handy unit and a switching power adaptor. The handy unit contains a programmed control circuit, high intensity dental blue LEI》 light source, a light quide and a optical fiber that conduct light to the treatment area on the patient. The control circuit which governs the output power rate, timing and monitoring the temperature of the LED.
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K Number
K041303Device Name
LED TURBO-PEN
Manufacturer
APOZA ENTERPRISE CO. LTD.
Date Cleared
2004-06-18
(32 days)
Product Code
EBZ
Regulation Number
872.6070Why did this record match?
Applicant Name (Manufacturer) :
APOZA ENTERPRISE CO. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LED Turbo-Pen is a dental curing light that is designed for use in the optical polymerization of dental resins.
Device Description
The LED Turbo-Pen consists of a handy unit and a battery charger. The handy unit contains a programmed control circuit, high intensity dental blue LED light source, a light guide and a optical fiber that conduct light to the treatment area on the patient. The control circuit which governs the output power rate. timing and monitoring the temperature of the LED.
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K Number
K033198Device Name
APOZA ULTRASONIC SCALER AND EDODONTICS UNIT, SELECTOR U2
Manufacturer
APOZA ENTERPRISE CO. LTD.
Date Cleared
2004-04-30
(211 days)
Product Code
ELC
Regulation Number
872.4850Why did this record match?
Applicant Name (Manufacturer) :
APOZA ENTERPRISE CO. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Apoza Selector U2 is designed for the dentists to remove the calculus or stains on surface of teeth er clean the root canal ( with endo-kit) in the prophylaxis procedures.
Device Description
Not Found
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K Number
K040618Device Name
LED TURBO
Manufacturer
APOZA ENTERPRISE CO. LTD.
Date Cleared
2004-03-25
(16 days)
Product Code
EBZ
Regulation Number
872.6070Why did this record match?
Applicant Name (Manufacturer) :
APOZA ENTERPRISE CO. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LED Turbo is a dental curing light that is designed for use in the polymerization of dental resins and the activation of bleaching materials.
Device Description
The LED Turbo consists of a handy unit and a battery charger. The handy unit contains a programmed control circuit, high intensity dental blue LED light source, a light guide and a optical fiber that conduct light to the treatment area on the patient. The control circuit which governs the output power rate, timing and monitoring the temperature of the LED.
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K Number
K033201Device Name
LA500 BLUE LIGHT
Manufacturer
APOZA ENTERPRISE CO. LTD.
Date Cleared
2003-12-02
(61 days)
Product Code
EBZ
Regulation Number
872.6070Why did this record match?
Applicant Name (Manufacturer) :
APOZA ENTERPRISE CO. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
LA500 Blue Light is a visible curing unit programmed for This polymerization of light cured materials by dental professionals..
Device Description
APOZA CURING LIGHT, Models: LA500 Blue Light. The intended use of the LA500 Blue Light is for the polymerization of light cure material and activation of dental bleaching materials.
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