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510(k) Data Aggregation

    K Number
    K252004

    Validate with FDA (Live)

    Device Name
    enCore Night Guard
    Manufacturer
    Encore Guards
    Date Cleared
    2025-11-25

    (151 days)

    Product Code
    OBR
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K200125,K221369
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The enCore Night Guard is indicated for protection of teeth and restorations against grinding and clenching.

    Device Description

    The enCore Night Guard is a mouth guard used as a barrier between teeth for nighttime teeth grinding by creating physical separation between upper and lower tooth surfaces preventing tooth damage caused by bruxism (e.g., grinding and clenching).

    AI/ML Overview

    N/A

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