Emerald Herbst

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…

Registry build 21.09.26

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.

8manufacturers in China registered for this device type
141catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (6), Zhejiang (1), Fujian (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code LRK
Manufacturer City Province Registered as Device types
Modern Dental Laboratory (DG) Co., Ltd. Dongguan Guangdong Contract manufacturer 15
Xiamen Yizhou IMP. & EXP. Co., Ltd. Xiamen Fujian Contract manufacturer 10
Dongguan Yiyao Science & Technology Development Co., Ltd. Dongguan Guangdong Contract manufacturer 2
Dongyang City Yonoel Outdoor Products Co., Ltd. Dongyang Zhejiang Contract manufacturer 32
Digital Dental Depot Zhuhai Guangdong Contract manufacturer 17
Shenzhen Sany Pioneer Technology Co., Ltd. Shenzhen Guangdong Manufacturer 9
Zhuhai DS Dental Technology Co., Ltd. Zhuhai Guangdong Manufacturer 8
Shenzhen Kesite Digital Technology Co., Ltd. Shenzhen Guangdong Contract manufacturer 4

Record

Regulatory record for Emerald Herbst
Listed by Island Dental LAB DBA Emerald Dental LAB, United States
FDA product code LRK
Device type Device, Anti-Snoring
Device class Class 2
Regulation 21 CFR 872.5570
Establishment Manufacturer
510(k) K223624
Record published 2025-04-01

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Prescription Prescription only
Label carries lot or batch number, serial number

Catalogue Numbers

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Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
EMA The Myerson Company Limited 94
Apnea Guard Advanced Brain Monitoring, Inc. 32
SML Selane Products, Inc. 32
SomnoDent Avant Somnomed, Ltd. 11
Itus Mouthguardz Shinrin-Yoku Traders LLC 8
Virtus Somnomed, Ltd. 7
Silent Nite Sleep Appliance with Glidewell Hinge Prismatik Dentalcraft, Inc. 7
ZQuiet S.A. Sleeping Well, LLC 6
Zyppah A.M.A. Plastics 6
AIRvance™ Medtronic Xomed, Inc. 5
Anti-snoring, restoration Modern Dental Laboratory (DG) Co., Ltd. 4
EMA Custom The Myerson Company Limited 4

Showing 12 of 209. All products under Device, Anti-Snoring

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer