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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
    K091533
    Device Name
    SLICKS SECTIONAL MATRIX AND MATRIX BANDS, MODELS SM100, SM150, SM175, SM200, SM300, SMH100, SMH150, SMH175 AND SMH200
    Date Cleared
    2009-08-17

    (83 days)

    Product Code
    Regulation Number
    872.4565
    Why did this record match?
    Applicant Name (Manufacturer) :

    GARRISON DENTAL SOLUTIONS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The device is used in combination with other dental devices to retain composite or amalgam restorative materials during dental restorations.
    Device Description
    Matrix bands are used to retain composite and other restorative materials during dental restorations. In general a matrix band surrounds the tooth and is used to separate the teeth while a composite filling is placed. The type of band is selected based on the tooth height and restoration type. The dentist prepares the tooth and places the band on the tooth. A wedge is inserted for optimal contour, gingival seal, and tooth separation. A ring retainer such as the Composi-Tight 3D Ring or Composi-Tight 3D Thin Tine G Ring is used to hold the band in place. The band is removed after the application of composite resin. The devices are offered in different thicknesses, lengths, and widths to accommodate different sized teeth. Additionally, the device is offered in soft stainless steel and hard stainless steel depending on the preference of the dentist. The devices are offered in sectional matrix style or standard style (Tofflemire style). The Tofflemire style is a longer thinner band with or without lobes. The choice of style is dependent on the preference of the dentist and the specific condition and size of the patient's teeth.
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