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510(k) Data Aggregation
K Number
K123410Device Name
HEALTHY SLEEP APPLIANCE
Manufacturer
Date Cleared
2013-04-05
(151 days)
Product Code
Regulation Number
872.5570Why did this record match?
Applicant Name (Manufacturer) :
HEALTHY SLEEP DENTAL LABORATORY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Healthy Sleep Appliance is intended for use in patients 18 years of age or older for the reduction of snoring and mild to moderate obstructive sleep apnea.
Device Description
The Healthy Sleep Appliance is a mandibular repositioning oral appliance used to treat snoring and mild to moderate obstructive sleep apnea. It is composed of an upper and a lower tray made to fit the occlusal surface of the teeth. These full arch trays are connected to each other by stainless steel arms that are set to conform to the predetermined occlusal relationship of the upper and lower arches. These arms have an adjusted length that can be adjusted as needed to exert a forward force on the lower jaw and advance the mandible relative to the maxilla. The advancement of the lower jaw increases the patient's pharyngeal space which facilitates improved air exchange.
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