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Emerald Herbst

FDA UDI

Class II (US FDA UDI)

by Island Dental Lab Dba Emerald Dental Lab

Identity

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

Identifiers

Primary DI / UDI-DI
DR7070153 FDA UDI
510(k) Number
K223624 FDA UDI
FDA Product Code
LRK FDA UDI
LQZ 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

Yes

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

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Mandible-repositioning/palate-lifting sleep-disordered breathing orthosis

Emerald Herbst by Island Dental Lab Dba Emerald Dental Lab — 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.

Cleared under the same submission

K223624 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Island Dental Lab Dba Emerald Dental Lab

Sources (1)

  • FDA UDI e318047f-7db6-4e9d-b207-90c017170f88 34 fields · synced May 31, 2026