Diamond Orthotic Lab

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Device, Anti-Snoring (LRK) (1)

Premarket Exempt

Clear

Diamond Digital Sleep Orthotic (DDSO) - 00860005253807 Catalog Number :

Device Description : The Diamond Digital Sleep Orthotic (DDSO) is a removable intraoral device intend 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.

Device Class : 2

Duns Number: 074127453

Premarket Exempt : No

Product Code : LRK

Prescription Use : Yes

Device Count : 1

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