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510(k) Data Aggregation

    K Number
    K093084
    Device Name
    ROLENCE DENTAL HIGH SPEED HANDPIECE, RHP
    Manufacturer
    ROLENCE ENT. INC.
    Date Cleared
    2009-12-16

    (76 days)

    Product Code
    EFB
    Regulation Number
    872.4200
    Why did this record match?
    Applicant Name (Manufacturer) :

    ROLENCE ENT. INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ROLENCE Dental High Speed Handpiece, model: RHP is intended for removing carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations and restorations and polishing teeth.
    Device Description
    According to ISO7785-1:1997, Dental Handpiece . -- Part 1: High-speed air turbine handpieces; and ISO13485:2003, Medical Device Quality Management System to complete the device design steps.
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    K Number
    K023545
    Device Name
    ULTRA-LITE 200E LIGHT CURE UNIT
    Manufacturer
    ROLENCE ENT. INC.
    Date Cleared
    2002-12-30

    (69 days)

    Product Code
    EBZ
    Regulation Number
    872.6070
    Why did this record match?
    Applicant Name (Manufacturer) :

    ROLENCE ENT. INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    THE ULTRA-LITE 200E IS A LIGHT CURE UNIT INTENDED FOR POLYMERIZATION OF LIGHT CURED MATERIAL BY DENTAL PROFESSIONALS.
    Device Description
    Not Found
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    K Number
    K020874
    Device Name
    ULTRA-LITE 5 TURBO LIGHT CURE UNIT
    Manufacturer
    ROLENCE ENT. INC.
    Date Cleared
    2002-06-12

    (86 days)

    Product Code
    EBZ
    Regulation Number
    872.6070
    Why did this record match?
    Applicant Name (Manufacturer) :

    ROLENCE ENT. INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    THE ULTRA-LITE 5 TURBO IS A LIGHT CURE UNIT INTENDED FOR POLYMERIZATION OF LIGHT CURED MATERIAL BY DENTAL PROFESSIONALS .
    Device Description
    Not Found
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    K Number
    K020877
    Device Name
    EXCELLITE TURBO LIGHT CURE UNIT
    Manufacturer
    ROLENCE ENT. INC.
    Date Cleared
    2002-06-12

    (86 days)

    Product Code
    EBZ
    Regulation Number
    872.6070
    Why did this record match?
    Applicant Name (Manufacturer) :

    ROLENCE ENT. INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    THE EXCELLITE TURBO IS A.LIGHT CURE UNIT INTENDED FOR POLYMERIZATION OF LIGHT CURED MATERIAL BY DENTAL PROFESSIONALS.
    Device Description
    EXCELLITE TURBO LIGHT CURE UNIT
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    K Number
    K020884
    Device Name
    EXCELLITE LIGHT CURE UNIT
    Manufacturer
    ROLENCE ENT. INC.
    Date Cleared
    2002-06-12

    (86 days)

    Product Code
    EBZ
    Regulation Number
    872.6070
    Why did this record match?
    Applicant Name (Manufacturer) :

    ROLENCE ENT. INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    THE EXCELLITE IS A LIGHT CURE UNIT INTENDED FOR POLYMERIZATION OF LIGHT CURED MATERIAL BY DENTAL PROFESSIONALS .
    Device Description
    Not Found
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