Dorsal Comfort Fit

Primary DI
00860009255609
Brand
Dorsal Comfort Fit
Company
Crane Dental Laboratory, Inc.
Model
0001
Device 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.
Published
2023-03-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LRKDevice, Anti-Snoring

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRKDevice, Anti-SnoringDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K181416000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181416000Sapphire Dorsal Comfort FitCrane Dental Laboratory, Inc.2019-09-17LRK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860009255609PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860009255609008600092556098600092556090860009255609

GMDN Terms#

Term, Definition table
TermDefinition
Mandible-repositioning/palate-lifting sleep-disordered breathing orthosisA removable intraoral device designed alleviate sleep-disordered breathing conditions (e.g., snoring, obstructive sleep apnoea) by repositioning the lower jaw (mandible), frequently in a downward and forward position, and by elevating the soft palate (soft tissue constituting the back of the roof of the mouth). It works by locking the mandible (e.g., holding the teeth) and preventing it from retruding and by applying pressure to lift a drooping soft palate, thus increasing the patency of the airway and decreasing both air turbulence and airway obstruction. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
940632037
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860009255616Sapphire Herbst00022023-03-21

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Primary DI, Brand, Company table
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