AccessGUDID - DEVICE: Emerald Herbst (DR8054668)

GUDID

Device Identifier (DI) Information

Brand Name: Emerald Herbst
Version or Model: Emerald Herbst
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Island Dental Lab Inc. DBA Emerald Dental Lab

Primary DI Number: DR8054668
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 111807817 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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

FDA Product Code

[?]

Product Code	Product Code Name
LRK	Device, Anti-Snoring
LQZ	Device, Jaw Repositioning

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K223624	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: bcb3b70a-dcc6-4b57-aee1-3dda84265011
Public Version Date: April 09, 2025
Public Version Number: 1
DI Record Publish Date: April 01, 2025