Device, Jaw Repositioning

Who Makes This Device Type in China?

4 manufacturers in China hold an FDA registration for this device type, based in Guangdong and Fujian. 2 of them are contract manufacturers, able to build to a buyer’s own specification.

Digital Dental Depot Guangdong, contract manufacturer
Modern Dental Laboratory (DG) Co., Ltd. Guangdong, contract manufacturer
Shenzhen Sany Pioneer Technology Co., Ltd. Guangdong
Xiamen Yizhou IMP. & EXP. Co., Ltd. Fujian, contract manufacturer

How Is LQZ Classified?

Device, Jaw Repositioning is FDA product code LQZ, Class 2, 21 CFR 872.5570.

How Does It Reach the US Market?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. The review can be done by an FDA-accredited third party, which is usually faster. No clearance under this code names a Chinese applicant.

A registration is not a clearance: the plants above are set up to make it, and the 510(k) it is sold under is held by whoever files it, often the brand.

Device, Jaw Repositioning

Kava Herbst Dual Laminate

A Dental Dual laminate oral appliance intended for mandibular advancement and positioning during sleep therapy for the treatment of snoring and obstructive sleep apnea.

Device, Jaw Repositioning

Kava Dorsal Acrylic

A dental acrylic oral appliance intended for mandibular advancement and positioning during sleep therapy.

Device, Jaw Repositioning

Narval CC

The Narval CC mandibular repositioning device is a removable intraoral device used for the treatment of snoring and Obstructive Sleep Apnea (OSA). Similarly to other mandibular…

Device, Jaw Repositioning

Napa (Nocturnal Airway Patency Appliance)

A removable intraoral device intended to reduce both mild Obstructive Sleep Apnea and snoring. This is a reusable device.

Device, Jaw Repositioning

Slow Wave

Slow Wave: 2 catalogue numbers listed by Slow Wave, Inc., United States, under Device, Jaw Repositioning. 4 manufacturers in China are registered for this product code.

Device, Jaw Repositioning

Kava Herbst Acrylic

A custom acrylic oral appliance intended to support mandibular positioning during sleep therapy.

Device, Jaw Repositioning

The Slide®

Slide Acrylic.

Device, Jaw Repositioning

Kava Dorsal Dual Laminate

A Dental Dual-Laminate oral appliance intended for mandibular advancement and positioning during sleep therapy for the treatment of snoring and obstructive sleep apnea.

Device, Jaw Repositioning

EMA 3d

EMA 3D: 1 catalogue number listed by EMA-Sleep Inc, United States, under Device, Jaw Repositioning. 4 manufacturers in China are registered for this product code.

Device, Jaw Repositioning

Narval CC

Connecting Rods Pack - Lower Range

Device, Jaw Repositioning

Napa Appliance

Napa Appliance: 1 catalogue number listed by Great Lakes Dental Technologies, Ltd., United States, under Device, Jaw Repositioning. 4 manufacturers in China are registered for this product code.

Device, Jaw Repositioning

SML

Ucla MOD. Herbst-ONE Segment U OR L

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