Sapphire Herbst

The Crane Acrylic Herbst Appliance is comprised of upper and lower patient-specific acrylic splints, connected bilaterally via a telescoping Herbst mechanism that orients the jaw in a…

Registry build 21.09.26

The Crane Acrylic Herbst Appliance is comprised of upper and lower patient-specific acrylic splints, connected bilaterally via a telescoping Herbst mechanism that orients the jaw in a predetermined relationship. The Herbst mechanism allows the patient vertical and lateral range of movement while the jaws are oriented in the biting relationship determined by the positioning of the mechanism as it connects to the respective arch splint. The appliance positions the lower jaw forward and open vertically from its normal location which causes a protrusion in the mandible in relation to the maxilla. The appliance aims through this repositioning (which is temporary while the appliance is being used) to increase air exchange, and to reduce snoring and apnea by increasing pharyngeal space. The prescribing dentist determines the repositioning of the mandible through a patient-specific protrusive bite registration taken by the dentist. The dentist is also able to adjust the mandible’s position by altering the Herbst mechanism, and/or adjusting the acrylic portion of the device. The Acrylic Splint Herbst Appliance is removable by the patient, and is worn while sleeping to support the mandible in a forward position determined by the prescribing dentist.

8manufacturers in China registered for this device type
1catalogue number
2510(k) clearances naming this product code

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 Sapphire Herbst
Listed by Crane Dental Laboratory, United States
FDA product code LRK
Device type Device, Anti-Snoring
Device class Class 2
Regulation 21 CFR 872.5570
Establishment Contract manufacturer, Manufacturer
510(k) K140429
Record published 2023-03-21

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only

Catalogue Numbers

Catalogue numbers for Sapphire Herbst
Catalogue number Size Status
0002 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Emerald Herbst Island Dental LAB DBA Emerald Dental LAB 141
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

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

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K181416 2019-09-17
K140429 2014-09-11

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