Data / Medical devices / Device, Jaw Repositioning
Device, Jaw Repositioning (LQZ): 32 FDA-registered makers in 6 countries
32 establishments in 6 countries are registered with the FDA to make Device, Jaw Repositioning (product code LQZ, Class 2, 21 CFR 872.5570). 6 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 27 510(k) clearances under this code, the latest on February 23, 2024, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- LQZ
- Device class
- 2
- Regulation
- 872.5570
- Medical specialty
- Dental
Makers by country
| Country | Makers |
|---|---|
| United States | 24 |
| China | 4 |
| Canada | 1 |
| Hong Kong | 1 |
| Taiwan | 1 |
| Germany | 1 |
Makers of Device, Jaw Repositioning
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Great Lakes Dental Technologies, Ltd. | Tonawanda, NY, United States | Manufacturer | 2 | June 14, 1995 | 0 | 0 | 0 | api.fda.gov |
| Space Maintainers Lab | Chatsworth, CA, United States | Contract manufacturer, Manufacturer | 2 | July 27, 2017 | 0 | 0 | 0 | api.fda.gov |
| Aiomega, LLC | Tyler, TX, United States | Manufacturer | 1 | February 23, 2024 | 0 | 0 | 0 | api.fda.gov |
| Biotex, Inc. | Houston, TX, United States | Manufacturer | 1 | July 20, 2021 | 0 | 0 | 0 | api.fda.gov |
| Slow Wave, Inc. | Lakeway, TX, United States | Manufacturer | 1 | October 2, 2020 | 0 | 0 | 0 | api.fda.gov |
| Vivos Therapeutics INC. | Murray, KY, United States | Specification developer | 1 | January 28, 2020 | 0 | 0 | 0 | api.fda.gov |
| Apex Dental Sleep Lab | La Mesa, CA, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Apnomed, Inc. | Bellevue, WA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aurum Ceramic Dental Laboratories Ltd. | CALGARY Alberta, Canada | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Burbank Dental Laboratory | Burbank, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Crane Dental Laboratory | Rochester, NY, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Davis Dental Lab | Wyoming, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dental Prosthetic Services, Inc. | Cedar Rapids, IA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Digital Dental Depot | zhuhai Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Digital Dental Depot Limited | Hong Kong, Hong Kong | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ema-Sleep Inc | Bastrop, TX, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fissiontech LLC | New York, NY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Five Star Orthodontic Laboratory & Supply, Inc. | Denton, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gelb Practice | Dix Hills, NY, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gergens Orthodontic Lab | Phoenix, AZ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Island Dental Lab Dba Emerald Dental Lab | Valley Stream, NY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Johns Dental Laboratory | Terre Haute, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Koncept Innovators, LLC | Myrtle Beach, SC, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Modern Dental Laboratory (DG) Co., Ltd. | Dongguan Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Oral Arts Laboratory, Inc. | Huntsville, AL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ortho Solutions LC | Lake Saint Louis, MO, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Prosomnus Sleep Technologies | Pleasanton, CA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Sany Pioneer Technology Co., Ltd. | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shun Hsiang Plastic Co.,ltd. | Taoyuan, Taiwan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sicat GMBH & Co. KG | BONN North Rhine-Westphalia, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sleep Joy International LLC | Northport, NY, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xiamen Yizhou Imp. & Exp. Co., Ltd. | Xiamen Fujian, China | Contract manufacturer, Exporter to the US | 0 | 0 | 0 | 0 | api.fda.gov |
Updated February 23, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.