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510(k) Data Aggregation

    K Number
    K200077
    Device Name
    BioMin Restore Plus
    Manufacturer
    Dr. Collins, Inc.
    Date Cleared
    2020-11-06

    (297 days)

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

    Dr. Collins, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Prescription fluoride dentifrice for use in the prevention and treatment of dental sensitivity.
    Device Description
    BioMin® Restore Plus is a daily-use, prescription fluoride dentifrice use in the prevention and treatment of dental sensitivity through physical occlusion of dentin tubules. The formulation incorporates BioMin™ F (Calcium Fluoro-Phosphosilicate, a particular form of bioactive glass) as its active ingredient. When exposed to an aqueous environment, BioMin™ F undergoes a rapid surface reaction to form Fluorapatite, which is chemically similar to natural tooth mineral, allowing it to physically occlude tubules.
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    K Number
    K181965
    Device Name
    Restore Toothpaste
    Manufacturer
    Dr. Collins, Inc.
    Date Cleared
    2019-06-13

    (325 days)

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

    Dr. Collins, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Restore Toothpaste is a fluoride-free toothpaste intended for cleaning the tooth surface on a daily basis. The toothpaste is formulated to provide rapid and continual desensitization through mechanical occlusion of exposed dentinal tubule.
    Device Description
    Not Found
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