LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K253641

    Validate with FDA (Live)

    Device Name
    Owl Night Guard
    Manufacturer
    Owl Dental Lab, Inc.
    Date Cleared
    2026-02-26

    (99 days)

    Product Code
    OBR,MQC,OCO
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    Dental
    Age Range
    18 - 120
    Reference & Predicate Devices
    K200125,K251778,K211158
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Owl 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 Owl 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

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1