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Found 8 results
510(k) Data Aggregation
K Number
K133423Device Name
REST ASSURED EXTRA COMFORT NITE PROTECTOR
Manufacturer
RANIR LLC
Date Cleared
2013-12-20
(42 days)
Product Code
OBR
Regulation Number
N/AWhy 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.
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K Number
K120103Device Name
REST ASSURED GENERATION III DENTAL PROTECTOR
Manufacturer
RANIR LLC
Date Cleared
2012-02-03
(22 days)
Product Code
OBR
Regulation Number
N/AWhy 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.
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K Number
K112879Device Name
REST ASSURED READY TO WEAR NITE PROTECTOR
Manufacturer
RANIR LLC
Date Cleared
2012-01-27
(119 days)
Product Code
OBR
Regulation Number
N/AWhy 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.
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K Number
K103004Device Name
SNORE GUARD
Manufacturer
RANIR LLC
Date Cleared
2011-02-25
(140 days)
Product Code
LRK
Regulation Number
872.5570Why 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.
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K Number
K102118Device Name
SNORE GUARD ADVANCE
Manufacturer
RANIR LLC
Date Cleared
2010-09-08
(42 days)
Product Code
LRK
Regulation Number
872.5570Why 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.
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K Number
K094020Device Name
GRIND NO MORE GENERATION II
Manufacturer
RANIR LLC
Date Cleared
2010-01-25
(27 days)
Product Code
OBR
Regulation Number
N/AWhy 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.
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K Number
K091175Device Name
GRIND NO MORE VERSION 2 AND 3
Manufacturer
RANIR LLC
Date Cleared
2009-05-08
(16 days)
Product Code
OBR
Regulation Number
N/AWhy 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.
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K Number
K063229Device Name
REST ASSURED NITE PROTECTOR
Manufacturer
RANIR LLC
Date Cleared
2006-12-19
(55 days)
Product Code
OBR
Regulation Number
N/AWhy 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.
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