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510(k) Data Aggregation
K Number
K020893Device Name
NORAD NOCTURNAL ORAL AIRWAY DILATOR APPLIANCE
Manufacturer
DENNIS R. BAILEY, DDS
Date Cleared
2002-05-28
(70 days)
Product Code
LRK
Regulation Number
872.5570Why did this record match?
Applicant Name (Manufacturer) :
DENNIS R. BAILEY, DDS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NOrAD device (appliance) is indicated for use in patients who are snorers or have mild to moderate obstructive sleep apnea that has been medically diagnosed or are intolerant to nasalCPAP and wish to reducc and manage their condition while sleeping.
The device may be used in individuals who have had an overnight sleep study and do not have apaca or have mild to moderate obstructive sleep apnea and their physician has recommended the appliance. The device may also be indicated for a patient that snores and may have obstructive sleep apnea but their physician does not feel a sleep study is indicated and has recommended or referred the patient for appliance therapy. In many instances the decision will have been made after consultation has occurred between the dentist and the physician.
Device Description
This device has a hard outer component with heat sensitive material contained within that component. The heat sensitive material is softened and is what fits the appliance to the patient's teeth for securing the appliance in place. Hooks for conventional Orthodontic elastics exist on the outer component for the purpose of attaching the elastics to prevent the mandible from retruding. The upper component has two (2) hooks and the lower component has one (1) hook. This allows for various methods of elastic placement depending on the need(s) of the patient. There is ramping on both the upper and the lower to facilitate and guide the mandible forward when the patient is in occlusion. These ramps also provide a posterior stop for support of the mandible. The appliance also provides for full coverage of the dentition to prevent any tooth movement or occlusal changes. The teeth at the anterior of the appliance allow for indexing of the appliance at a position most acceptable to the patient during wear and allows the patient to determine the most effective jaw position for repositioning dependent on sleep position. The teeth index in such a way to allow for freedom of movement of the jaw during sleep while remaining in an indexed position.
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K Number
K013049Device Name
NORAD, NOCTURNAL ORAL AIRWAY DILATOR APPLIANCE
Manufacturer
DENNIS R. BAILEY, DDS
Date Cleared
2001-11-29
(79 days)
Product Code
LRK
Regulation Number
872.5570Why did this record match?
Applicant Name (Manufacturer) :
DENNIS R. BAILEY, DDS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NOrAD device is indicated for use in patients who are snorers and wish to reduce or otherwise manage their snoring while sleeping.
The device is to be used with individuals in whom it has been determined that they are primary snorers and are not at risk for sleep apnea. In many instances these individuals may have had a sleep study and have been found to have a Respiratory Disturbance Index (RDI) below the level that necessitates a diagnosis for sleep apnea. They may also be individuals who are snorers and whose physician has determined that they are not candidates for a sleep study and may proceed with management of their snoring utilizing this device. Many times this decision will have been achieved after consultation has occurred between the dentist and their physician.
Device Description
This device has a hard outer component with heat sensitive material contained within that component. The heat sensitive material is softened and is what fits the appliance to the patient's teeth for securing the appliance in place. Hooks for conventional Orthodontic elastics exist on the outer component for the purpose of attaching the elastics to prevent the mandible from retruding. The upper component has two (2) hooks and the lower component has one (1) hook. This allows for various methods of elastic placement depending on the need(s) of the patient. There is ramping on both the upper and the lower to facilitate and guide the mandible forward when the patient is in occlusion. These ramps also provide a posterior stop for support of the mandible. The appliance also provides for full coverage of the dentition to prevent any tooth movement or occlusal changes. The teeth at the anterior of the appliance allow for indexing of the appliance at a position most acceptable to the patient during wear and allows the patient to determine the most effective jaw position for repositioning dependent on sleep position. The teeth index in such a way to allow for freedom of movement of the jaw during sleep while remaining in an indexed position.
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