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510(k) Data Aggregation

    K Number
    K250028
    Date Cleared
    2025-10-03

    (270 days)

    Product Code
    Regulation Number
    872.5570
    Panel
    Dental
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Anti snore mouthpiece is intended as an aid in the reduction of snoring for adults at least 18 years old.

    Device Description

    Anti snore mouthpiece is an intraoral device composed of a maxillary and mandibular tray assembled to position the mandible forward relative to the maxilla to increase users' pharyngeal space and improve the ability to exchange air and decreases air turbulence, a causative factor in snoring.

    AI/ML Overview

    N/A

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