Diamond Digital Sleep Orthotic (DDSO)

GUDID 00860005253807

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.

Diamond Orthotic Lab

Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis Mandible-repositioning sleep-disordered breathing orthosis

• Primary Device ID: 00860005253807
• NIH Device Record Key: 59b5ad0d-039d-46b3-983f-d4dee819cc37
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Diamond Digital Sleep Orthotic (DDSO)
• Version Model Number: 1
• Company DUNS: 074127453
• Company Name: Diamond Orthotic Lab
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Keep at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Keep at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Keep at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Keep at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Keep at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Keep at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Keep at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Keep at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Keep at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Keep at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Keep at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Keep at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Keep at room temperature

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860005253807 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202499

FDA Product Code

• LRK: Device, Anti-Snoring

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-02
• Device Publish Date: 2020-09-24