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Sapphire Herbst

FDA UDI

Class II (US FDA UDI)

by Crane Dental Laboratory

Identity

Trade Name
Sapphire Herbst FDA UDI
Generic Name
Mandible-repositioning/palate-lifting sleep-disordered breathing orthosis FDA UDI
Device Name
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. FDA UDI
Model / Reference
0002 FDA UDI
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. 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. FDA UDI

Identifiers

Primary DI / UDI-DI
00860009255616 FDA UDI
510(k) Number
K140429 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

Sapphire Herbst 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 368d5c7b-f9ac-445c-8274-d9ec7d0dce2b 34 fields · synced Jun 1, 2026