Search Results
Found 1 results
510(k) Data Aggregation
K Number
K223624Device Name
Emerald Herbst
Manufacturer
Date Cleared
2023-05-10
(156 days)
Regulation Number
872.5570Why did this record match?
Applicant Name (Manufacturer) :
Island Dental Lab, Inc dba Emerald Dental
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Emerald Herbst appliance is intended to treat snoring and mild to moderate Obstructive Sleep Apnea (OSA) in adults 18 years of age or older.
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 and an adjustment screw. 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 is intended to treat snoring and mild to moderate sleep apnea (OSA) in adults 18 years of age or older by guiding the mandible forward during sleep, preventing the tongue and soft tissues of the throat from collapsing into the airway.
The Emerald Herbst is offered in two options:
- Hard devices which are all acrylic and retained with ball clasps that allow the device to be tightened if it becomes loose.
- Hard / Soft which has a laminate layer that provides a soft layer on the tooth surface.
Ask a Question
Ask a specific question about this device
Page 1 of 1