Search Filters

Search Results

Found 8 results

510(k) Data Aggregation

    K Number
    K133423
    Device Name
    REST ASSURED EXTRA COMFORT NITE PROTECTOR
    Manufacturer
    RANIR LLC
    Date Cleared
    2013-12-20

    (42 days)

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

    RANIR LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Rest Assured® Extra Comfort Nite Protector is indicated for use for protection against bruxism or night time teeth grinding. The device is intended to reduce damage to the teeth and to prevent the noise associated with bruxing or grinding.
    Device Description
    The Rest Assured Extra Comfort Nite Protector is indicated for protection against bruxism or nighttime teeth grinding. The device is intended to reduce damage to the teeth and to prevent the noise associated with bruxing or teeth grinding. The Rest Assured® Extra Comfort Nite Guard is an occlusive nightguard. fitted to the consumer by the "boil and bite" method.
    Ask a Question
    K Number
    K120103
    Device Name
    REST ASSURED GENERATION III DENTAL PROTECTOR
    Manufacturer
    RANIR LLC
    Date Cleared
    2012-02-03

    (22 days)

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

    RANIR LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Rest Assured Generation III Dental Protector is indicated for use for protection against bruxism or nighttime teeth grinding. The device is intended to reduce damage to the teeth and to prevent the noise associated with bruxing or grinding.
    Device Description
    The Rest Assured III is a fully occlusive nightguard, fitted to the patient by the "boil and bite" method. The Rest Assured III is the same device as Ranir's Rest Assured Generation II with the following minor differences: a reduction in the overall mass of the device, slight increase in arc width, additional impression material and base material, removal of sidewall material, addition of a small triangle fitting notch, and limited labeling changes.
    Ask a Question
    K Number
    K112879
    Device Name
    REST ASSURED READY TO WEAR NITE PROTECTOR
    Manufacturer
    RANIR LLC
    Date Cleared
    2012-01-27

    (119 days)

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

    RANIR LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Rest Assured Ready to Wear Nite Protector is indicated for use for protection against bruxism or nighttime teeth grinding. The device is intended to reduce damage to the teeth and to prevent the noise associated with bruxing or grinding.
    Device Description
    The Rest Assured Ready to Wear Nite Protector is a posterior-occlusive nightguard, comprised of two molar bite pads connected by a buccal retaining strap. The device is fit to the user's mouth by adjusting the bite plates along the retaining strap.
    Ask a Question
    K Number
    K103004
    Device Name
    SNORE GUARD
    Manufacturer
    RANIR LLC
    Date Cleared
    2011-02-25

    (140 days)

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

    RANIR LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Snore Guard is indicated for use in the treatment of nighttime snoring and mild to moderate Obstructive Sleep Apnea in adults 18 years of age or older.
    Device Description
    The Snore Guard consists of a mouthguard worn on the maxilla, connected to an occlusal stop (called an "occlusal ramp"), which contacts the patient's mandibular incisors. Both the maxillary tray and the occlusal ramp are custom fitted using a "boil-and-bite" process.
    Ask a Question
    K Number
    K102118
    Device Name
    SNORE GUARD ADVANCE
    Manufacturer
    RANIR LLC
    Date Cleared
    2010-09-08

    (42 days)

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

    RANIR LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Snore Guard Advance is intended to be used for the treatment of nighttime snoring and mild to moderate Obstructive Sleep Apnea in adults.
    Device Description
    The Snore Guard Advance consists of a mouthguard worn on the maxilla, connected to an occlusal stop (called an "occlusal ramp"), which contacts the patient's mandibular incisors. Both the maxillary tray and the occlusal ramp are custom fitted using a "boil-and-bite" process.
    Ask a Question
    K Number
    K094020
    Device Name
    GRIND NO MORE GENERATION II
    Manufacturer
    RANIR LLC
    Date Cleared
    2010-01-25

    (27 days)

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

    RANIR LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Grind No More Generation II is indicated for use for protection against bruxism or nighttime teeth grinding. The device is intended to reduce damage to the teeth and to prevent the noise associated with bruxing or grinding.
    Device Description
    Grind No More Generation II is an anterior and posterior occlusive mouthguard, consisting of two molar bite plates and an anterior bite plate connected by a buccal retention band. As with the predicate Grind No More 2, the molar bite plates are grooved with vertical positioners to engage the natural anatomy of the teeth for enhanced retention. The Grind No More Generation II has a similar design to the Grind No More 2, with the addition of the anterior bite plate.
    Ask a Question
    K Number
    K091175
    Device Name
    GRIND NO MORE VERSION 2 AND 3
    Manufacturer
    RANIR LLC
    Date Cleared
    2009-05-08

    (16 days)

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

    RANIR LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Grind No More Version 2 and Grind No More Version 3 are indicated for use for protection against bruxism or nighttime teeth grinding. The devices are intended to reduce damage to the teeth and to prevent the noise associated with bruxing or grinding.
    Device Description
    Grind No More 2 and Grind No More 3 are a posterior-only occlusive nightguards, consisting of two molar bite plates connected by a buccal retention band.
    Ask a Question
    K Number
    K063229
    Device Name
    REST ASSURED NITE PROTECTOR
    Manufacturer
    RANIR LLC
    Date Cleared
    2006-12-19

    (55 days)

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

    RANIR LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Rest Assured™ Nite Protector is indicated for protection against bruxism or night time teeth grinding. The device is intended to reduce damage to teeth and prevent noise associated with bruxing or grinding.
    Device Description
    The Rest Assured™ Nite Protector, as packaged, is initially composed of two components: (1) a moldable soft upper component made of Elvax® thermoplastic resin and (2) a hard temporary fitting tray made of biocompatible medical grade Santoprene™ When heated and cooled, the upper Elvax® portion of the mouthguard may be molded to fit the consumer's upper teeth. During the brief fitting process, the Santoprene™ temporary fitting tray maintains the shape of the upper material and prevents the user from biting through the upper material. After the desired fit is achieved, the temporary fitting tray is removed and discarded.
    Ask a Question

    Page 1 of 1