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510(k) Data Aggregation

    K Number
    K251778
    Device Name
    Remi Custom Night Guard
    Manufacturer
    Remi
    Date Cleared
    2025-10-17

    (129 days)

    Product Code
    OBR
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K200125,K221369,K211158
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Remi Custom Night Guard is Indicated for protection of teeth and restorations against grinding and clenching, and as an aid in the reduction of medically diagnosed migraine pain associated with jaw clenching and bruxing.

    Device Description

    The Remi 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).
    Remi Night Guards are manufactured using impressions and/or scans.

    AI/ML Overview

    N/A

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