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510(k) Data Aggregation

    K Number
    K100545
    Device Name
    SLEEPRIGHT
    Manufacturer
    POWER PRODUCTS, INC.-SPLINTEK
    Date Cleared
    2010-06-04

    (98 days)

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

    POWER PRODUCTS, INC.-SPLINTEK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SleepRight® Original is indicated for the protection against bruxism or night time teeth grinding. It is intended to reduce damage to the teeth and to prevent the noise associated with bruxing or grinding.
    Device Description
    An adjustable protector that provides a barrier between the upper and lower posterior teeth. The flexible connecting strap provides 5 adjustments for the bite pads.
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    K Number
    K071404
    Device Name
    SLEEP RIGHT - SELECT, LOW PROFILE AND ADVANCE
    Manufacturer
    POWER PRODUCTS, INC.-SPLINTEK
    Date Cleared
    2007-08-17

    (88 days)

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

    POWER PRODUCTS, INC.-SPLINTEK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Prescription Indications for Use: . Protection against teeth grinding, bruxism & jaw clenching. Short-term pain relief from muscle spasm due to occlusal interference. . For the prevention of chronic tension and TMJ caused by chronic jaw clenching of . the mandibular and maxillary teeth by the temporalis muscle. OTC Indications for Use: The SleepRight® adjustable night guard is indicated for the protection against bruxism or night time teeth grinding. It is intended to reduce damage to the teeth and to prevent the noise associated with bruxing or grinding.
    Device Description
    An adjustable protector that provides a barrier between the upper and lower posterior teeth. The flexible connecting strap provides 4 adjustments for articulating bite pads.
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    K Number
    K022809
    Device Name
    EZ SPLINT & EZ SPLINT PM
    Manufacturer
    POWER PRODUCTS, INC.-SPLINTEK
    Date Cleared
    2003-10-17

    (420 days)

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

    POWER PRODUCTS, INC.-SPLINTEK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Protection against teeth grinding, bruxism and jaw clenching. Short-term pain relief from muscle spasm due to occlusal interference. For the prevention of chronic tension and temporal mandibular joint (TMJ) syndrome that is caused by chronic jaw clenching of the mandibular and maxillary teeth.
    Device Description
    The devices are constructed of a thermal sensitive Elvax 4. strap and polypropylene and Kraton® bite pads. The bite pads may be adjusted for the individual patient. Although the two products look similar, the EZ-Splint, PM has an anatomically contoured shape for maximum cheek retention and stability during sleep. The EZ-Splint was designed as small as possible for speech and maximum flexibility when used in conjunction with dental and orthodontic work. The EZ-Splint's narrow shape makes it favorable for daytime use.
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