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510(k) Data Aggregation

    K Number
    K203477
    Device Name
    Classic
    Manufacturer
    Date Cleared
    2021-02-25

    (90 days)

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

    Orthoapnea S.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Classic is a Mandibular Advancement Device (MAD) indicated for mild to moderate obstructive sleep apnea (OSA) and to alleviate or reduce snoring in adults.
    Device Description
    Classic device is an intraoral device specially indicated for the treatment of snoring and obstructive sleep apnea syndrome. Its design makes it simple to use and comfortable to wear. It is intended for single-patient use by adults who are 18 years or older. Classic device consists of two splints united to each other by a screw that allows controlled advancement of the mandible by the increase of the muscular tone at the airway level. Consequently, the flow of air through the upper airway is increased, and reducing snoring and apnea events. The maximum protrusion of Classic arch form is 10 mm, measuring from patient's plate. This device needs an external controlling component such as screwdriver included in the kit. The device is according arches, maximizes tongue space and allow open, close and laterality movements during wear. These movements can be personalized by the doctor. Each Classic device has the following components: 1. Upper splint 2. Lower splint 3. Activation key 4. Guide (Bar) 5. OrthoApnea screw
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    K Number
    K202651
    Device Name
    NOA Sleep Apnea and Snoring Device
    Manufacturer
    Date Cleared
    2021-02-12

    (151 days)

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

    Orthoapnea S.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    NOA SLEEP APNEA AND SNORING DEVICE is a mandibular advance device (MAD) indicated for mild to moderate obstructive sleep apnea (OSA) and to alleviate or reduce snoring in adults.
    Device Description
    The NOA Sleep Apnea and Snoring Device is a customized prescription intraoral mandibular advancement device for snoring and obstructive sleep apnea intended for single-patient use by those who are 18 years or older. The device consists of CAD/CAM fabricated maxillary and mandibular splints connected by symmetrical, twin-mated posts that are customizable to allow lateral jaw movement as well as jaw opening. The series of one or more mandibular splints, and one or more maxillary splints to be exchanged with other splints in the series according to the prescriber, to titrate protrusive jaw movement according to patient comfort and needs. The described mandibular advancement is intended to reduce snoring and mild to moderate obstructive sleep apnea by holding the mandible and base of tongue forward during sleep, to provide increased pharyngeal space to improve the patient's ability to exchange air and decrease air turbulence. The NOA Sleep Apnea and Snoring Device does not have any additional adjustment mechanisms to modify or maintain the mandibular position such as pistons, straps, repositioning elastics or screws, eliminating the need for utilizing external controlling components such as keys, screwdrivers or ligature ties. The NOA device is designed with lateral fins called cam and follower. Contact between the cam and the follower prevents any mandibular retrusion even with the opening of the mouth. The device design is configured according to the patient's specific dental arch, to maximize tongue space and to allow open, close and laterality movements during wear. These movements can be personalized by the doctor. Furthermore, the doctor can change the height of the cam in the prescription to limit the maximum mouth opening during wear. Orthoapnea NOA device designs can be Standard or Customized. A Standard device is designed with standard height in the lateral cams among all lower splints. If the practitioner provides a measurement of the antero-posterior mobility (Maximum retrusion), a Customized device is designed decreasing the height of the cam according to the degree of advancement. increases, the ability to open the mouth without mandibular retrusion decreases, making the cam shorter. The following additional device design features can be customized when ordering the prescription device: Advance regulation/titration sequence, Lateral movement, Device opening limit, Frontal opening of the device.
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