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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

CountryMakers
United States24
China4
Canada1
Hong Kong1
Taiwan1
Germany1

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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Great Lakes Dental Technologies, Ltd.Tonawanda, NY, United StatesManufacturer2June 14, 1995000api.fda.gov
Space Maintainers LabChatsworth, CA, United StatesContract manufacturer, Manufacturer2July 27, 2017000api.fda.gov
Aiomega, LLCTyler, TX, United StatesManufacturer1February 23, 2024000api.fda.gov
Biotex, Inc.Houston, TX, United StatesManufacturer1July 20, 2021000api.fda.gov
Slow Wave, Inc.Lakeway, TX, United StatesManufacturer1October 2, 2020000api.fda.gov
Vivos Therapeutics INC.Murray, KY, United StatesSpecification developer1January 28, 2020000api.fda.gov
Apex Dental Sleep LabLa Mesa, CA, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Apnomed, Inc.Bellevue, WA, United StatesSpecification developer0000api.fda.gov
Aurum Ceramic Dental Laboratories Ltd.CALGARY Alberta, CanadaContract manufacturer0000api.fda.gov
Burbank Dental LaboratoryBurbank, CA, United StatesManufacturer0000api.fda.gov
Crane Dental LaboratoryRochester, NY, United StatesContract manufacturer0000api.fda.gov
Davis Dental LabWyoming, MI, United StatesContract manufacturer0000api.fda.gov
Dental Prosthetic Services, Inc.Cedar Rapids, IA, United StatesContract manufacturer0000api.fda.gov
Digital Dental Depotzhuhai Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Digital Dental Depot LimitedHong Kong, Hong KongExporter to the US, Manufacturer0000api.fda.gov
Ema-Sleep IncBastrop, TX, United StatesSpecification developer0000api.fda.gov
Fissiontech LLCNew York, NY, United StatesManufacturer0000api.fda.gov
Five Star Orthodontic Laboratory & Supply, Inc.Denton, TX, United StatesContract manufacturer0000api.fda.gov
Gelb PracticeDix Hills, NY, United StatesSpecification developer0000api.fda.gov
Gergens Orthodontic LabPhoenix, AZ, United StatesContract manufacturer0000api.fda.gov
Island Dental Lab Dba Emerald Dental LabValley Stream, NY, United StatesManufacturer0000api.fda.gov
Johns Dental LaboratoryTerre Haute, IN, United StatesContract manufacturer0000api.fda.gov
Koncept Innovators, LLCMyrtle Beach, SC, United StatesSpecification developer0000api.fda.gov
Modern Dental Laboratory (DG) Co., Ltd.Dongguan Guangdong, ChinaContract manufacturer0000api.fda.gov
Oral Arts Laboratory, Inc.Huntsville, AL, United StatesContract manufacturer0000api.fda.gov
Ortho Solutions LCLake Saint Louis, MO, United StatesManufacturer0000api.fda.gov
Prosomnus Sleep TechnologiesPleasanton, CA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Shenzhen Sany Pioneer Technology Co., Ltd.Shenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Shun Hsiang Plastic Co.,ltd.Taoyuan, TaiwanContract manufacturer0000api.fda.gov
Sicat GMBH & Co. KGBONN North Rhine-Westphalia, GermanyManufacturer0000api.fda.gov
Sleep Joy International LLCNorthport, NY, United StatesSpecification developer0000api.fda.gov
Xiamen Yizhou Imp. & Exp. Co., Ltd.Xiamen Fujian, ChinaContract manufacturer, Exporter to the US0000api.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.