Sapphire Herbst

Primary DI
00860009255616
Brand
Sapphire Herbst
Company
Crane Dental Laboratory, Inc.
Model
0002
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 predeterminedrelationship. The Herbst mechanism allows the patient vertical and lateral range of movementwhile the jaws are oriented in the biting relationship determined by the positioning of themechanism as it connects to the respective arch splint.The appliance positions the lower jaw forward and open vertically from its normal location whichcauses a protrusion in the mandible in relation to the maxilla. The appliance aims through thisrepositioning (which is temporary while the appliance is being used) to increase air exchange, andto reduce snoring and apnea by increasing pharyngeal space.The prescribing dentist determines the repositioning of the mandible through a patient-specificprotrusive bite registration taken by the dentist. The dentist is also able to adjust the mandible'sposition by altering the Herbst mechanism, and/or adjusting the acrylic portion of the device. TheAcrylic Splint Herbst Appliance is removable by the patient, and is worn while sleeping to supportthe mandible in a forward position determined by the prescribing dentist.
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
K140429000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140429000CRANE ACRYLIC HERBST APPLIANCECrane Dental Laboratory, Inc.2014-09-11LRK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860009255616PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860009255616008600092556168600092556160860009255616

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
00860009255609Dorsal Comfort Fit00012023-03-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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D775IBABN0Bonded LowerGreat Lakes Dental Technologies, Ltd.LRK2026-04-13
D775IBAE0Banded Herbst -RPEGreat Lakes Dental Technologies, Ltd.LRK2026-04-13
D775IBAEBN0Rpe Bonded LowerGreat Lakes Dental Technologies, Ltd.LRK2026-04-13
D775IBAER0Banded Herbst-Rpe Remov LowerGreat Lakes Dental Technologies, Ltd.LRK2026-04-13
D775IBAR0Banded Herbst -Removable LowerGreat Lakes Dental Technologies, Ltd.LRK2026-04-13
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