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510(k) Data Aggregation
K Number
K152159Device Name
Oravan Herbst
Manufacturer
Date Cleared
2015-10-29
(87 days)
Product Code
Regulation Number
872.5570Why did this record match?
Applicant Name (Manufacturer) :
OravanOSA, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Oravan Herbst is intended to reduce snoring and mild to moderate sleep apnea in adults.
Device Description
The Oravan Herbst is intended to reduce snoring and mild to moderate sleep apnea in adults. It is made of orthodontic acrylic trays and herbst assembly. It has two acrylic pieces - the upper acrylic tray that fits over the top posterior teeth and the lower acrylic tray that fits over the bottom posterior teeth. The herbst assembly provides a standard titration mechanism and enables mandibular advancement. With this design, the Oravan Herbst allows the physician to increase the patient's pharyngeal opening, improving their ability to exchange air during sleep and reduce vibrations. Each Oravan Herbst device is patient-specific (customized for each patient).
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