DEVICE: Sapphire Herbst (00860009255616)

Device Identifier (DI) Information

Sapphire Herbst
0002
In Commercial Distribution

Crane Dental Laboratory, Inc.
00860009255616
GS1

1
940632037 *Terms of Use
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. 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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Device Characteristics

Labeling does not contain MRI Safety Information
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GMDN

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GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
47527 Mandible-repositioning/palate-lifting sleep-disordered breathing orthosis
A 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.
Active false
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FDA Product Code

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Product Code Product Code Name
LRK Device, Anti-Snoring
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K140429 000
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Sterilization

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Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

368d5c7b-f9ac-445c-8274-d9ec7d0dce2b
March 29, 2023
1
March 21, 2023
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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None
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Production Identifier(s) in UDI

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Customer Contact

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No Customer Contact currently defined
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