Emerald Herbst
Basic Information
- Brand Name
- Emerald Herbst
- Primary DI
- DS1071567
- Version / Model
- Emerald Herbst
- Company Name
- Island Dental Lab Inc. DBA Emerald Dental Lab
- Labeler DUNS
- 111807817
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-04-01
- Public Version
- 1
- Public Version Date
- 2025-04-09
- Public Version Status
- New
- Public Device Record Key
- 4b80a870-778e-4603-b985-664163d1263c
Device Description
The Emerald Herbst appliance is a customized oral device featuring both lower and upper trays and interlocking system. The product is non-sterile, biocompatible, and provided in a sealed box with instructions for use. The upper and lower trays are connected by an adjustable hinge allowing the patient to open and close the mouth while wearing the appliance. The Herbst Telescopic Hardware on the side of the device allows the patient to move forward and left and right but not backwards. This freedom of movement is important for comfort and overall success of the device. The Emerald Herbst appliance treats snoring and mild to moderate sleep apnea by guiding the mandible forward during sleep, preventing the tongue and soft tissues of the throat from collapsing into the airway.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LRK | Device, Anti-Snoring | Dental | 872.5570 | 2 |
| LQZ | Device, Jaw Repositioning | Dental | 872.5570 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | DS1071567 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K223624 | 000 |