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510(k) Data Aggregation

    K Number
    K241238
    Device Name
    LOOP™ LED Curing Light System (CLK01)
    Date Cleared
    2024-08-01

    (90 days)

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

    Garrison Dental Solutions, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The LOOP™ is a source of illumination for curing photo-activated dental restorative materials and adhesives.
    Device Description
    LOOP™ is a high-performance LED (Light Emitting Diode) light source for polymerization of dental materials used by trained dental professionals. It is suitable for use with a broad range of light-cured dental materials including materials for restoratives such as light-cured and dual-cure cements, composites, bonding agents/adhesives, bases, liners, fissure sealants, temporaries, as well as luting materials for brackets and indirect restorations such as ceramic inlays. LOOP™ consists of a wireless handpiece and a charging base with an integrated calibration station. The device is a medical electrical device in accordance with IEC 60601-1-2. LOOP™ features a patented coaxial feedback sensing system that measures the actual irradiance, which is the light power striking the targeted tooth. The feedback data allows LOOPTM to make corrective adjustments to the LED power output hundreds of times per second. This continual corrected "closed loop" operation ensures that the targeted surface of the restorative dental material receives the intended irradiance independent of operator-induced distance variations.
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    K Number
    K200775
    Device Name
    LOOP LED Curing Light System
    Date Cleared
    2020-08-14

    (142 days)

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

    Garrison Dental Solutions, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The LOOP is a source of illumination for curing photo-activated dental restorative materials and adhesives.
    Device Description
    LOOP™ is a LED (Light Emitting Diode) light source for polymerization of dental materials for use by trained dental professionals. It is suitable for use with a broad range of light-cured dental materials including materials for restoratives such as light-cured and dual-cure cements, composites, bonding agents/adhesives, bases, liners, fissure sealants, temporaries, as well as luting materials for brackets and indirect restorations such as ceramic inlays. LOOP™ consists of a wireless handpiece and a charging base with an integrated calibration station. The device is a medical electrical device in accordance with IEC 60601-1-2. LOOP™ features a patented coaxial feedback sensing system that measures the actual irradiance, which is the light power striking the targeted tooth. The feedback data allows LOOP™ to make corrective adjustments to the LED power output hundreds of times per second. This continual corrected "closed loop" operation ensures that the targeted surface of the restorative dental material receives the intended irradiance independent of operator-induced distance variations.
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    K Number
    K160498
    Device Name
    Dentivera Milling Disc
    Date Cleared
    2016-06-15

    (113 days)

    Product Code
    Regulation Number
    872.3760
    Why did this record match?
    Applicant Name (Manufacturer) :

    Dental Solutions, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Dentivera™ Milling Disc is a thermoplastic denture base resin designed for the manufacture of full and partial removable dentures and overdentures.
    Device Description
    The Dentivera™ Milling Discs are cylindrical, puck-shaped discs made from Ultaire™ AKP, an arylketone thermoplastic polymer resin with zinc oxide (ZnO) as an additive stabilizer. The milling discs are machined into partial or full removable denture frames using available dental CAD/CAM systems. The nominal dimensions are 98 mm in diameter and 28 mm thick.
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