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Dorsal Comfort Fit

FDA UDI

Class II (US FDA UDI)

by Crane Dental Laboratory

Identity

Trade Name
Dorsal Comfort Fit FDA UDI
Generic Name
Mandible-repositioning/palate-lifting sleep-disordered breathing orthosis FDA UDI
Device Name
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. FDA UDI
Model / Reference
0001 FDA UDI
Description
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. FDA UDI

Identifiers

Primary DI / UDI-DI
00860009255609 FDA UDI
510(k) Number
K181416 FDA UDI
FDA Product Code
LRK FDA UDI
GMDN Term
Mandible-repositioning/palate-lifting sleep-disordered breathing orthosis FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.5570 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

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

Dorsal Comfort Fit by Crane Dental Laboratory — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Mandible-repositioning/palate-lifting sleep-disordered breathing orthosis.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Crane Dental Laboratory

Sources (1)

  • FDA UDI d2f23012-3b37-4c27-8adf-39b93d35dabc 34 fields · synced May 30, 2026