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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
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K101104,K181965
    Why did this record match?
    Device Name :

    BioMin Restore Plus

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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.

    AI/ML Overview

    The provided text is a 510(k) summary for the device "BioMin® Restore Plus," a fluoride dentifrice intended to prevent and treat dental sensitivity by occluding dentin tubules. Here's a breakdown of the acceptance criteria and study information:

    1. Acceptance Criteria and Reported Device Performance

    The acceptance criteria for "BioMin® Restore Plus" are primarily based on its ability to perform comparably to its predicate devices in terms of dentin tubule occlusion and safety (abrasivity).

    Acceptance Criteria ItemReported Device Performance
    Dentine Tubule Occlusion Effectiveness"BioMin® Restore Plus is as effective as the primary predicate device at dentine tubule occlusion."
    Relative Dentin Abrasivity (RDA)"The Relative Dentin Abrasivity (RDA) value is similar to the primary predicate and is well under the limit considered safe for daily use (
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