Dorsal Comfort Fit

GUDID 00860009255609

The Sapphire Dorsal Comfort Fit is an intraoral device used for treating snoring and mild to moderate obstructive sleep apnea. It consists of custom fitted trays which fit over the upper and lower teeth. The device functions as a mandibular repositioner, which acts to increase the patient’s pharyngeal space during sleep and improves their ability to exchange air during sleep. The device is custom made for each patient and has an expansion screw adjustment mechanism enabling the amount of mandibular advancement to be set by the dentist or physician at the time of fitting the device.

Crane Dental Laboratory, Inc.

Mandible-repositioning/palate-lifting sleep-disordered breathing orthosis

• Primary Device ID: 00860009255609
• NIH Device Record Key: d2f23012-3b37-4c27-8adf-39b93d35dabc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dorsal Comfort Fit
• Version Model Number: 0001
• Company DUNS: 940632037
• Company Name: Crane Dental Laboratory, Inc.
• 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: false
• Serial Number: false
• Manufacturing Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860009255609 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181416

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: 2023-03-29
• Device Publish Date: 2023-03-21

Devices Manufactured by Crane Dental Laboratory, Inc.

• 00860009255609 - Dorsal Comfort Fit: 2023-03-29The Sapphire Dorsal Comfort Fit is an intraoral device used for treating snoring and mild to moderate obstructive sleep apnea. It consists of custom fitted trays which fit over the upper and lower teeth. The device functions as a mandibular repositioner, which acts to increase the patient’s pharyngeal space during sleep and improves their ability to exchange air during sleep. The device is custom made for each patient and has an expansion screw adjustment mechanism enabling the amount of mandibular advancement to be set by the dentist or physician at the time of fitting the device.
• 00860009255609 - Dorsal Comfort Fit: 2023-03-29 The Sapphire Dorsal Comfort Fit is an intraoral device used for treating snoring and mild to moderate obstructive sleep apnea. I
• 00860009255616 - Sapphire Herbst: 2023-03-29 The Crane Acrylic Herbst Appliance is comprised of upper and lower patient-specific acrylic splints, connected bilaterally via a