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510(k) Data Aggregation

    K Number
    K120109
    Device Name
    SUPER SEAL TOOTH DESENSITIZER
    Manufacturer
    PHOENIX DENTAL, INC.
    Date Cleared
    2012-03-07

    (54 days)

    Product Code
    LBH
    Regulation Number
    872.3260
    Why did this record match?
    Applicant Name (Manufacturer) :

    PHOENIX DENTAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To aid in the relief from dentinal sensitivity caused by cold, heat, acids, sweets, or as the result from dental whitening agents.
    Device Description
    Super Seal ® Tooth Desensitizer is applied with an applicator by the user to aid in dentinal sensitivity. It contains an organic salt that reacts with the calcium hydroxyapatite in the dentinal tubules. The formation of these calcium oxalate crystals inhibits and blocks fluid flow in the tubules, thereby relieving dentinal sensitivity.
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    K Number
    K102821
    Device Name
    DISCOVRED
    Manufacturer
    PHOENIX DENTAL, INC.
    Date Cleared
    2011-03-11

    (164 days)

    Product Code
    LFC
    Regulation Number
    872.1740
    Why did this record match?
    Applicant Name (Manufacturer) :

    PHOENIX DENTAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DiscovRED™ is indicated for use to detect carious dentin.
    Device Description
    The product, DiscovRED™, is classified into the Caries Detection Device category of CFR 21, Section 872.1740. DiscovRED™, as well as the Predicate Device, Caries Detector, is a red dye agent that when applied to the suspected carious areas of the tooth stains the carious dentine. DiscovRED™ is a caries detector. Both devices have a two year shelf-life. DiscovRED™ is for Prescription Use only and not over-the-counter use. The method of operation and placement of DiscovRED™ is similar to that of the Predicate Device, Caries Detector. A drop of the detector is applied to the carious dentine, rinsed with water and air dispersed. The stained carious tissue is then removed with a low speed rotary bur. The process may be repeated until there are no more stainable tissues in the cavity. DiscovRED™ and the Predicate Device do not involve chemical reactions. DiscovRED™ and the Predicate Device do not use any power-assisted devices such as optical light emitting or electrical energy forms.
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    K Number
    K983477
    Device Name
    SUPER SEAL
    Manufacturer
    PHOENIX DENTAL, INC.
    Date Cleared
    1998-12-22

    (81 days)

    Product Code
    EJK
    Regulation Number
    872.3250
    Why did this record match?
    Applicant Name (Manufacturer) :

    PHOENIX DENTAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Super Seal is a potassium oxalate based film forming acid resistant liner and desensitizer that is indicated for application prior to restoration of exposed dentin.
    Device Description
    Super Seal is a potassium oxalate based film forming acid resistant liner and desensitizer.
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