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510(k) Data Aggregation

    K Number
    K061228
    Manufacturer
    Date Cleared
    2006-05-26

    (24 days)

    Product Code
    Regulation Number
    872.5570
    Panel
    Dental
    Reference & Predicate Devices
    Why did this record match?
    Device Name :

    FULL BREATH SLEEP APPLIANCE WITH POSTERIOR TONGUE DEPRESSOR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    1. Full Breath Sleep Appliance With Posterior Tongue Depressor- This appliance is indicated for the treatment of snoring.
    2. Full Breath Sleep Appliance With Posterior Tongue Depressor This appliance is indicated for the treatment of mild to moderate obstructive sleep apnea.
    Device Description

    Not Found

    AI/ML Overview

    The provided text does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria. Instead, it is a 510(k) summary and FDA decision letter for a medical device called the "Full Breath Sleep Appliance With Posterior Tongue Depressor."

    Here's what the document does provide:

    • Device Name: Full Breath Sleep Appliance With Posterior Tongue Depressor (and other variations)
    • Applicant: Bryan Keropian DDS
    • Proposed Product Code: LQZ
    • Proposed Device Classification: Jaw Repositioning Device
    • Indications for Use:
      • Treatment of snoring
      • Treatment of mild to moderate obstructive sleep apnea
    • Substantial Equivalence (SE) Claim: The device claims substantial equivalence to several predicate devices for the treatment of mild and moderate OSA, snoring, and bruxism.

    The document focuses on establishing substantial equivalence to previously cleared devices rather than presenting new performance data against specific acceptance criteria. This is common for 510(k) submissions, where the primary goal is to show that a new device is as safe and effective as a legally marketed predicate device.

    Therefore, I cannot populate the requested table or provide information about a study proving acceptance criteria as that data is not present in the provided text.

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