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510(k) Data Aggregation

    K Number
    K973884
    Device Name
    ELASTIC MANDIBULAR ADVANCEMENT - TITRATION (EMA-T) APPILANCE
    Manufacturer
    FRANTZ DESIGN, INC.
    Date Cleared
    1998-01-09

    (87 days)

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

    FRANTZ DESIGN, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Temporary treatment of obstructive sleep apnea and snoring to determine in which patients mandibular advancement and opening the bite will increase the patients air space
    Device Description
    The EMA-T appliance is a modified functional orthodontic appliance. The modifications are: 1) clasps are not needed as the appliance is retained firmly to the teeth by dental impression material into undercut areas. Each tray holds the teeth in their present location not allowing tooth movement. 2) the bite is opened with bite planes as in the Elastic Mandibular Advancement appliance. 3) the mandible is advanced with an elastic strap similar to the Elastic Mandibular Advancement appliance. The appliance is designed for universal application in adults with the use of one-sizefits all maxillary and mandibular hard plastic trays. On the night of the titration polysomnogram, the sleep technician makes impressions of the maxillary and mandibular teeth by placing a fast setting dental silicone putty material (such as E and D Dental Products Incorporated) in the tray and pushing the tray onto the patient's teeth. The trays and putty with the patient's impression are removed from the mouth. Just before the start of the sleep study, the impression and the patient's teeth are dried off. A liguid silicone "wash" is placed onto the patient's impression and placed on the maxillary and mandibular teeth and arches for the duration of the study. This "wash" holds the trays firmly on the patient's teeth and prevents their dislodgment during sleep. On the anterior of the maxillary tray is a rod that protrudes at the midline in front of the patient's central incisors. A Styrene Block Copolymer strap with a pull tab and holes 3 millimeters apart is connected to the mandibular tray. Mandibular advancement is achieved by pulling the tab forward and inserting the rod into one of the holes on the pull tab. The mandible is thereby held in an advanced position by the stationary maxilla, and is advanced in 3 millimeter increments. As the sleep lab technician advances the mandible, the polysomnogram will show a decrease, or even an elimination, of the patient's apneas on those responding. A prescription will then be given to the patient for a permanent custom made oral appliance.
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    K Number
    K971794
    Device Name
    ELASTIC MANDIBULAR ADVANCEMENT (EMA) APPLIANCE
    Manufacturer
    FRANTZ DESIGN, INC.
    Date Cleared
    1997-09-29

    (137 days)

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

    FRANTZ DESIGN, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Treatment of nasal respiratory dysfunction of obstructive sleep apnea and snoring in those patients where repositioning of the mandible can increase the patients air space.
    Device Description
    The Elastic Mandibular Advancement appliance is a modified functional orthodontic appliance. The modifications are: 1) clasps are not needed as the appliance is retained firmly to the teeth by pressure formed plastic into the undercut areas. Each tray holds the teeth in their present location not allowing tooth movement. 2) the bite is opened as in the SNOAR and NAPA appliances but not in one fixed position. Multiple bite openings are possible because of removable bite blocks or bite planes of varying thicknesses. 3) the mandible is advanced as in both the SNOAR and NAPA appliances except not in a fixed position , but in various amounts of forward advancement because of removable, replaceable elastic bands or straps to pull the mandible forward.
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