| Primary Device ID | 00860009255616 |
| NIH Device Record Key | 368d5c7b-f9ac-445c-8274-d9ec7d0dce2b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Sapphire Herbst |
| Version Model Number | 0002 |
| Company DUNS | 940632037 |
| Company Name | Crane Dental Laboratory, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| 00860009255609 - Dorsal Comfort Fit | 2023-03-29 The Sapphire Dorsal Comfort Fit is an intraoral device used for treating snoring and mild to moderate obstructive sleep apnea. I |
| 00860009255616 - Sapphire Herbst | 2023-03-29The 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. |
| 00860009255616 - Sapphire Herbst | 2023-03-29 The Crane Acrylic Herbst Appliance is comprised of upper and lower patient-specific acrylic splints,
connected bilaterally via a |