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510(k) Data Aggregation

    K Number
    K093059
    Device Name
    SELECT DEFENSE DENTAL PIT AND FISSURE SEALANT
    Date Cleared
    2010-02-04

    (127 days)

    Product Code
    Regulation Number
    872.3765
    Why did this record match?
    Applicant Name (Manufacturer) :

    CLASSONE ORTHODONTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    SeLECT Defense Dental Pit and Fissure Sealant is a BisGMA based light cured resin for the sealing of deciduous teeth and the filling of fissures in primary tooth structure.
    Device Description
    Not Found
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    K Number
    K080445
    Device Name
    LION SE ONE STEP ORTHODONTIC ADHESIVE
    Date Cleared
    2008-07-16

    (148 days)

    Product Code
    Regulation Number
    872.3750
    Why did this record match?
    Applicant Name (Manufacturer) :

    CLASSONE ORTHODONTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This device is intended for bonding brackets to teeth for orthodontic treatment.
    Device Description
    Lion Se is a one step orthodontic adhesive. It comprises of two major components, i.e., a viscous polymeric resin paste and a watery component called. Activator. The formulation of Lion Se adhesive is identical to the predicate adhesive, except that the Lion Se paste contains 2% of a Selenium compound . This is a modified acrylic monomer which polymerizes & becomes an integral part of the final cured adhesive. The paste is delivered from a syringe, while the activator is dispensed from a squeeze bottle. Besides the paste & the activator, the product kit contains a preloaded syringe of etchant (35% phosphoric acid solution), brushes to apply the activator on the tooth and a stack of mixing pads for easy transfer of the activator.
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    K Number
    K053379
    Device Name
    RELI-ON ONE STEP, ORTHODONTIC ADHESIVE
    Date Cleared
    2006-01-25

    (51 days)

    Product Code
    Regulation Number
    872.3750
    Why did this record match?
    Applicant Name (Manufacturer) :

    CLASSONE ORTHODONTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This device is intended for bonding brackets to teeth for orthodontic treatment.
    Device Description
    Reli-On is a one step orthodontic adhesive. It comprises of two major components, i.e., a viscous polymeric resin paste and a watery component called. Activator. The paste is delivered from a syringe, while the activator is dispensed from a squeeze bottle. Besides the paste & the activator, the product kit contains a preloaded syringe of etchant (35% phosphoric acid solution), brushes to apply the activator on the tooth and a stack of mixing pads for easy transfer of the activator.
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