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510(k) Data Aggregation

    K Number
    K192581
    Device Name
    The NightBlocks Appliance
    Manufacturer
    Advanced Facialdontics LLC
    Date Cleared
    2020-01-28

    (131 days)

    Product Code
    LQZ, LOZ, LRK
    Regulation Number
    872.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    Advanced Facialdontics LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NightBlocks™ Appliance is intended to reduce nighttime snoring and mild to moderate obstructive sleep apnea in adults. The NightBlocks™ Appliance is worn while sleeping to support the lower jaw in a forward position prescribed by the dentist. The customized appliance is inserted and removed by the patient and adjusted by the prescribing dentist.
    Device Description
    The NightBlocks™ appliance consist of two removable, custom fabricated acrylic trays that fit separately over the upper and lower dental arches and engage each other in order to reposition the mandible in a slightly anterior position. They contain stainlesssteel ball clasps for extra retention and stainless-steel orthodontic expansion screws on the buccal portion of the upper tray that engage with the dorsal wings of the lower tray. The trays occlude on the left or right molar and premolar region. Every device is custom prescribed and fabricated for each patient from dental models and is adjustable at the time of delivery and anytime thereafter as it is intended to be used in the home setting. The principal of operation is jaw repositioning. Worn during sleep, the NightBlocks™ function as a mandibular advancement device which acts to increase the patient's pharyngeal airway space, improving their ability to exchange air during sleep. The anterior repositioning of the mandible prevents the tongue from sliding backward or downward for a prone sleeping individual. Therefore, the airway will be larger, contributing to the reduction in snoring and mild to moderate sleep apnea. Materials: Polymethylmethacrylate Polymer and Monomer (Lang Orthodontic Acrylic K141439), medical grade stainless steel wire (AJ Wilcock), and orthodontic stainlesssteel expansion screws (Leone).
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    K Number
    K182820
    Device Name
    The POD
    Manufacturer
    Advanced Facialdontics LLC
    Date Cleared
    2019-07-17

    (286 days)

    Product Code
    MQC, OCO
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    Advanced Facialdontics LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The POD® is for the amelioration of clenching associated with TMD and is to be used to aid in the relief of symptoms of TMD/TMJ.
    Device Description
    The POD® is a prescription only, removable dental mouthguard worn on the mandibular arch during sleep. The one-piece device is fabricated for the mandibular arch and can be customized for each patient based on the clinician prescription. The dentist obtains a dental impression, prescribes the design, and once laboratory fabricated, delivers the custom-made device at the dental office to be used in the home setting. Materials: Polymethyl methacrylate (PMMA Acrylic Resin - Orthocryl®) and medical grade stainless steel wire. Only the PMMA has body contact as the SS wire is embedded within the PMMA and does not contact the body. Duration and type of contact: Surface device with a limited duration (<24 h) contact of the skin and of mucosal membranes. The subject device provides a disocclusion that protects the teeth and restorations while helping to reduce symptoms of pain and headaches.
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