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510(k) Data Aggregation
K Number
K181416Device Name
Sapphire Dorsal Comfort Fit
Manufacturer
Date Cleared
2019-09-17
(474 days)
Product Code
Regulation Number
872.5570Why did this record match?
Applicant Name (Manufacturer) :
Crane Dental Laboratory, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Sapphire Dorsal Comfort Fit Appliance is intended for use in patients 18 years of age or older for the reduction of night time snoring and mild to moderate obstructive sleep apnea.
Device Description
The Sapphire Dorsal Comfort Fit Appliance is an intraoral device used for reducing snoring and mild to moderate obstructive sleep apnea. It consists of 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 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.
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K Number
K140429Device Name
CRANE ACRYLIC HERBST APPLIANCE
Manufacturer
Date Cleared
2014-09-11
(204 days)
Product Code
Regulation Number
872.5570Why did this record match?
Applicant Name (Manufacturer) :
CRANE DENTAL LABORATORY, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Crane Acrylic Herbst Appliance is intended for use in patients 18 years of age or older for the reduction of night time snoring and mild to moderate obstructive sleep apnea.
Device Description
The Crane Acrylic Herbst Appliance is comprised of upper and lower patient-specific acrylic splints connected bilaterally via a telescoping Herbst mechanism that orients the jaw in a predetermined relationship. The Herbst mechanism allows the patient vertical and lateral range of movement while the jaws are oriented in the biting relationship determined by the positioning of the mechanism as it connects to the respective arch splint. The Appliance positions the lower jaw forward and open vertically from its normal location which causes a protrusion in the mandible in relation to the maxilla. The appliance aims through this repositioning (which is temporary while the appliance is being used) to increase air exchange, and to reduce snoring and apnea by increasing pharyngeal space.
The prescribing dentist determines the repositioning of the mandible through a patient-specific protrusive bite registration taken by the dentist is also able to adjust the mandible's position by altering the Herbst mechanism, and/or adjusting the acrylic portion of the device. The Acrylic Splint Herbst Appliance is removable by the patient, and is worn while sleeping to support the mandible in a forward position determined by the prescribing dentist.
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