Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K232735
    Device Name
    EMA 3D
    Manufacturer
    EMA Sleep Incorporated
    Date Cleared
    2024-05-03

    (239 days)

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

    EMA Sleep Incorporated

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EMA 3D is a removable medical device that is fitted in the patient's mouth and is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA) in adults.
    Device Description
    The EMA 3D device is a simple hardware device. It is an oral appliance and will be manufactured by a dental laboratory to and on the order of a dentist, physician or licensed practitioner. Each appliance is customized for patients. The EMA 3D device is intra-oral device used for treating snoring and mild to moderate Obstructive Sleep Apnea (OSA). It has a patented button hook design with variable elastic band for optimum titration with bitewing if needed. The device consists of two custom fitted trays which fit over the upper and lower dentition of a patient. The trays are standard biocompatible trays that do not reposition teeth. Each tray holds the teeth in their present location not allowing tooth movement. The devices function as mandibular repositioners, which act to increase the patient's pharyngeal space by reducing obstructions of the airway during sleep and improve their ability to exchange air. There are four button hooks utilized on the EMA 3D device (two hooks per tray, two trays top and bottom. The hooks must be placed at a distance of 21mm apart from the top tray hook to the bottom tray hook center to center. Though there is no requirement except the opitimum location for hook placement between the top and bottom trays is on the upper bicuspid and the lower first molar. Button hooks and bite blocks for the EMA 3D utilize standard dimensions. These button hooks serve as fastening anchors for Elastic Straps that come in four different color coded strengths: White-Soft, Yellow-Medium, Blue-Firm and Clear- Extra Firm. These straps also come in 9 different lengths such that the Dental Professional can ensure the patient specific correct amount of mandibular advancement the lengths are as follows: 21mm, 20mm, 19mm, 18mm, 17mm, 16mm, 15mm, 14mm, 13mm.
    Ask a Question

    Page 1 of 1