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510(k) Data Aggregation
K Number
K202499Device Name
Diamond Digital Sleep Orthotic (DDSO)
Manufacturer
Diamond Orthotic Laboratory
Date Cleared
2020-09-03
(3 days)
Product Code
LRK
Regulation Number
872.5570Why did this record match?
Applicant Name (Manufacturer) :
Diamond Orthotic Laboratory
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Diamond Digital Sleep Orthotic (DDSO) is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA) in adults.
Device Description
The Diamond Digital Sleep Orthotic (DDSO) is a removable intraoral device intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA) in adults. The device functions as a mandibular repositioner, maintaining the lower jaw in a forward, (protrusive) position during sleep. This mechanical protrusion acts to increase the patient's pharyngeal space and decrease air turbulence, therefore improving their ability to exchange air during sleep.
The DDSO is a patient-matched prescription medical device, indicated for use during sleep to treat patients who snore and/or have mild to moderate obstructive sleep apnea. The design consists of two splints that fit independently over the upper and lower teeth and engage by means of an adjustable mechanism. This mechanism enables the practitioner to set the amount of mandibularadvancement at the time of fitting the device.
The amount of titration (mandibular protrusion) ranges from in 1.0 mm increments.
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