Search Results
Found 1 results
510(k) Data Aggregation
K Number
K130067Device Name
MRNA APPLIANCE
Manufacturer
BIOMODELING SOLUTIONS, LLS
Date Cleared
2014-05-08
(483 days)
Product Code
LRK
Regulation Number
872.5570Why did this record match?
Applicant Name (Manufacturer) :
BIOMODELING SOLUTIONS, LLS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For the treatment of snoring and mild to moderate obstructive sleep apnea in adults.
Device Description
The mRNA appliance is an intraoral device used for treating and mild to moderate sleep apnea, functioning as a mandibular repositioner and acting to increase the patient's pharyngeal space to improve the ability to exchange air. It consists of two customized trays that fit over the upper and lower teeth. An adjustment mechanism enables the device to be customized for each patient.
The mRNA appliance is a customized oral device featuring both lower (optional) and upper interlocking trays. These trays prevent the collapsing of the tissues in the back of the throat and preserves the airway.
The mRNA appliance consists of upper and lower interlocking, customized trays. The mRNA appliance is customized on models of the patient's teeth, using standard orthodontic acrylics and standard orthodontic wires for clasps and retention. The mRNA appliance allows for interlocking of the upper and lower trays; the mandibular position may be adjusted antero-posteriorly (AP), transversely (TV), as well as permitting adjustments of the vertical dimension of occlusion (VDO). The interlocking of the upper and lower trays to permit adjustments in the vertical dimension is the primary unique feature of this design.
Ask a Question
Page 1 of 1