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510(k) Data Aggregation
K Number
K143623Device Name
Narval Brux
Manufacturer
RESMED SAS
Date Cleared
2015-08-13
(234 days)
Product Code
MQC
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
RESMED SAS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Narval Brux is intended for protection of teeth and restorations from the forces of bruxism.
Device Description
The Narval Brux is a removable intraoral device used for protecting teeth and restorations aqainst the forces of bruxism. It consists of patient-specific splints that fit separately over the upper or lower teeth. The design of the splints is dependent on the patient needs.
The device functions as a protective barrier for teeth and restorations by creating physical separation between posterior occlusal surfaces and/or anterior incisal edges which will prevent tooth damage caused by grinding, bruxing and may help alleviate jaw and muscle pain.
The device is customized for each patient based on the clinician prescription.
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K Number
K113201Device Name
NARVAL CC
Manufacturer
RESMED SAS
Date Cleared
2011-12-01
(31 days)
Product Code
LQZ
Regulation Number
872.5570Why did this record match?
Applicant Name (Manufacturer) :
RESMED SAS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Narval CC™ is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA) in adults.
Device Description
The Narval CC is a removable intraoral device used for treating snoring and sleep apnea. It consist of two custom fabricated splints that fit separately over the upper and lower teeth and engage by means of adjustable rods. The device functions as a mandibular repositioner, maintaining the lower jaw in a forward position during sleep. This mechanical protrusion acts to increase the patient's pharyngeal space, improving his/her ability to exchange air and reducing the tendency to snore. The device is custom made for each patient and has an adjustment mechanism enabling the amount of mandibular advancement to be set by the dentist or physician at the time of fitting.
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