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Data / Medical devices / Device, Anti-Snoring

Device, Anti-Snoring (LRK): 95 FDA-registered makers in 17 countries

95 establishments in 17 countries are registered with the FDA to make Device, Anti-Snoring (product code LRK, Class 2, 21 CFR 872.5570). 64 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 217 510(k) clearances under this code, the latest on October 20, 2026, and lists 5 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
LRK
Device class
2
Regulation
872.5570
Medical specialty
Dental

Makers by country

CountryMakers
United States66
China8
Canada3
Australia2
France2
Germany2
India2
Philippines1
Hong Kong1
Spain1
New Zealand1
Switzerland1
South Korea1
Trinidad and Tobago1
Thailand1
Costa Rica1
Taiwan1

Makers of Device, Anti-Snoring

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
Ortho Solutions LCLake Saint Louis, MO, United StatesContract manufacturer, Manufacturer8May 31, 2022000api.fda.gov
Sleeping Well, LLCShelburne, VT, United StatesSpecification developer6June 15, 2022000api.fda.gov
Somnomed Inc.Plano, TX, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler6June 12, 2026000api.fda.gov
Somnomed, Ltd.CROWS NEST New South Wales, AustraliaSpecification developer6June 12, 2026000api.fda.gov
SomnoMed Phillipines Inc.Makati City National Capital Region, PhilippinesManufacturer6June 12, 2026000api.fda.gov
Vivos Therapeutics INC.Murray, KY, United StatesRepackager or relabeler, Specification developer5December 30, 2022000api.fda.gov
Airway Management Inc.Farmers Branch, TX, United StatesComplaint file establishment, Contract manufacturer, Manufacturer4September 11, 2025000api.fda.gov
Always More Marketing IncCalabasas, CA, United StatesSpecification developer4January 24, 2019000api.fda.gov
Open Airway Dental Solutions Australia Pty LtdTaringa Queensland, AustraliaManufacturer4August 29, 2019000api.fda.gov
Apex Dental Sleep LabLa Mesa, CA, United StatesContract manufacturer, Manufacturer, Repackager or relabeler3May 3, 2024000api.fda.gov
Digital Dental Depotzhuhai Guangdong, ChinaExporter to the US, Manufacturer3June 11, 2026000api.fda.gov
Digital Dental Depot LimitedHong Kong, Hong KongExporter to the US, Manufacturer3June 11, 2026000api.fda.gov
Fissiontech LLCNew York, NY, United StatesManufacturer3October 29, 2025000api.fda.gov
Prismatik Dentalcraft, Inc.Irvine, CA, United StatesComplaint file establishment, Contract manufacturer, Manufacturer3November 14, 2023010api.fda.gov
Prosomnus Sleep TechnologiesPleasanton, CA, United StatesComplaint file establishment, Manufacturer3October 6, 2022000api.fda.gov
Shenzhen Sany Pioneer Technology Co., Ltd.Shenzhen Guangdong, ChinaManufacturer3August 27, 2026000api.fda.gov
Sleep Science Partners, Inc.Larkspur, CA, United StatesSpecification developer3April 11, 2019000api.fda.gov
American Sleep DentistryCedar City, UT, United StatesManufacturer2June 8, 2017000api.fda.gov
Apnea Sciences CorporationHenderson, NV, United StatesManufacturer2August 18, 2017000api.fda.gov
Crane Dental LaboratoryRochester, NY, United StatesContract manufacturer, Manufacturer2September 17, 2019000api.fda.gov
Doc Brands, Inc.Knoxville, TN, United StatesComplaint file establishment, Repackager or relabeler, Specification developer2December 11, 2019000api.fda.gov
Gergens Orthodontic LabPhoenix, AZ, United StatesContract manufacturer, Manufacturer2July 17, 2013000api.fda.gov
Good Sleep Co Usa LLCGrand Prairie, TX, United StatesManufacturer2October 24, 2025000api.fda.gov
Great Lakes Dental Technologies, Ltd.Tonawanda, NY, United StatesContract manufacturer, Manufacturer2March 20, 1996000api.fda.gov
Koncept Innovators, LLCMyrtle Beach, SC, United StatesSpecification developer2May 14, 2026000api.fda.gov
Medtronic Xomed, Inc.Jacksonville, FL, United StatesManufacturer2January 10, 2013010api.fda.gov
OnirisRUEIL MALMAISON Hauts-de-Seine, FranceManufacturer2September 4, 2025000api.fda.gov
Orthoapnea S.L.Malaga, SpainManufacturer2February 25, 2021000api.fda.gov
Panthera Dental IncQuebec City, CanadaComplaint file establishment, Manufacturer2February 22, 2018000api.fda.gov
Shenzhen Kesite Digital Technology Co., Ltd.Shenzhen Guangdong, ChinaManufacturer2September 18, 2023000api.fda.gov
The Snore Reliever CompanyLargo, FL, United StatesRepackager or relabeler, Specification developer2January 14, 2021000api.fda.gov
True Function Laboratory IncLa Mesa, CA, United StatesContract manufacturer, Manufacturer2February 11, 2019000api.fda.gov
Tomed GmbHKoeln North Rhine-Westphalia, GermanyManufacturer2September 28, 2012000api.fda.gov
Advanced Brain Monitoring, Inc.Carlsbad, CA, United StatesManufacturer1July 22, 2011000api.fda.gov
Advantech Plastics, LLCWoodstock, IL, United StatesManufacturer1June 22, 2010000api.fda.gov
Aiomega, LLCTyler, TX, United StatesManufacturer1November 6, 2025000api.fda.gov
Apnomed, Inc.Bellevue, WA, United StatesSpecification developer1November 21, 2018000api.fda.gov
Boyd ResearchSt Pete Beach, FL, United StatesManufacturer1May 3, 2005000api.fda.gov
Burbank Dental LaboratoryBurbank, CA, United StatesContract manufacturer, Manufacturer1May 3, 2024000api.fda.gov
Diamond Orthotic Laboratory, LLCLa Mesa, CA, United StatesContract manufacturer, Manufacturer1September 3, 2020000api.fda.gov
Dongguan Yiyao Science & Technology Development Co., Ltd.Dongguan City Guangdong, ChinaContract manufacturer, Manufacturer1October 3, 2025000api.fda.gov
Ema-Sleep IncBastrop, TX, United StatesSpecification developer1May 3, 2024000api.fda.gov
Gelb PracticeDix Hills, NY, United StatesSpecification developer1February 14, 2024000api.fda.gov
Island Dental Lab Dba Emerald Dental LabValley Stream, NY, United StatesManufacturer1May 10, 2023000api.fda.gov
Innovative Health Technologies (NZ) LimitedDunedin Otago, New ZealandManufacturer1December 21, 1999000api.fda.gov
Keller LaboratoriesFenton, MO, United StatesContract manufacturer, Manufacturer1October 16, 2014000api.fda.gov
MPOWRX HEALTH AND WELLNESS PRODUCTS 2012 Inc.Calgary Alberta, CanadaComplaint file establishment, Specification developer1January 3, 2020000api.fda.gov
NewsomParis, FranceManufacturer1December 15, 2016000api.fda.gov
Oscimed SALA CHAUX-DE-FONDS, NE Neuchatel, SwitzerlandManufacturer1January 16, 2024000api.fda.gov
QuietLab LLCNew York, NY, United StatesSpecification developer1December 5, 2025000api.fda.gov
Ranir LLCGrand Rapids, MI, United StatesComplaint file establishment, Specification developer1September 8, 2010000api.fda.gov
Reazeal CorpWilmington, DE, United StatesManufacturer1October 3, 2025000api.fda.gov
Respironics Inc.Murrysville, PA, United StatesComplaint file establishment, Specification developer1February 6, 2004000api.fda.gov
Shinrin-Yoku Traders LLCSherwood, OR, United StatesManufacturer1December 2, 2022000api.fda.gov
Sicat GMBH & Co. KGBONN North Rhine-Westphalia, GermanyManufacturer1March 31, 2016000api.fda.gov
Sleep Joy International LLCNorthport, NY, United StatesSpecification developer1August 18, 2010000api.fda.gov
Smartguard RX IncLayton, UT, United StatesSpecification developer1August 23, 2021000api.fda.gov
Solbaro Co.,ltd.Eumseong Chungbuk, South KoreaManufacturer1November 10, 2022000api.fda.gov
Serena SleepHudson, WI, United StatesManufacturer1March 10, 2021000api.fda.gov
Splintek Inc.Lenexa, KS, United StatesManufacturer1May 19, 2025000api.fda.gov
The Metz Dental LaboratoryGahanna, OH, United StatesManufacturer, Specification developer1April 5, 2013000api.fda.gov
The Myerson Company LimitedLaventille San JuanLaventille, Trinidad and TobagoManufacturer, Specification developer1September 29, 1997000api.fda.gov
Xiamen Yizhou Imp. & Exp. Co., Ltd.Xiamen Fujian, ChinaContract manufacturer, Exporter to the US1November 23, 2020000api.fda.gov
Zhuhai DS Dental Technology Co., LtdZhuhai Guangdong, ChinaManufacturer1April 5, 2013000api.fda.gov
3DPX MedicalChicago, IL, United StatesContract manufacturer0000api.fda.gov
Artisan Laboratories IncPortland, OR, United StatesContract manufacturer0000api.fda.gov
Aurum Ceramic Dental Laboratories Ltd.CALGARY Alberta, CanadaContract manufacturer0000api.fda.gov
Bialex LabWichita Falls, TX, United StatesManufacturer0000api.fda.gov
Biotex, Inc.Houston, TX, United StatesManufacturer0000api.fda.gov
Comfort Acrylics, Inc.Camas, WA, 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
Dongyang City Yonoel Outdoor Products Co.,ltdDongyang Zhejiang, ChinaExporter to the US, Manufacturer, Repackager or relabeler0000api.fda.gov
Drake Precision Dental Laboratory, Inc.Charlotte, NC, United StatesContract manufacturer0000api.fda.gov
Five Star Orthodontic Laboratory & Supply, Inc.Denton, TX, United StatesContract manufacturer0000api.fda.gov
GCDL, LLCProspect Heights, IL, United StatesContract manufacturer0000api.fda.gov
Global Dent Aids Private LimitedNOIDA Uttar Pradesh, IndiaContract manufacturer0000api.fda.gov
Green Dental LabHeber Springs, AR, United StatesContract manufacturer0000api.fda.gov
Hexa Ceram Co., Ltd.Sansai Chiang Mai, ThailandContract manufacturer0000api.fda.gov
Idoc Dental LabOrange, CA, United StatesContract manufacturer0000api.fda.gov
Inventex MedicalNiles, IL, United StatesContract manufacturer0000api.fda.gov
Ironwood Industries, Inc.Libertyville, IL, United StatesContract manufacturer0000api.fda.gov
Johns Dental LaboratoryTerre Haute, IN, United StatesContract manufacturer0000api.fda.gov
Laboratorios Dentales De Zona Franca, S.A.Cartago, Costa RicaContract manufacturer0000api.fda.gov
Life Science Outsourcing, Inc.Brea, CA, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
M R Utility Products Private LimitedNoida Uttar Pradesh, IndiaContract manufacturer0000api.fda.gov
Modern Dental Laboratory (DG) Co., Ltd.Dongguan Guangdong, ChinaContract manufacturer0000api.fda.gov
New Image Dental Laboratory, Inc.Morrow, GA, United StatesContract manufacturer0000api.fda.gov
Oral Arts Laboratory, Inc.Huntsville, AL, United StatesContract manufacturer0000api.fda.gov
R-Dent Dental Laboratory, IncBartlett, TN, United StatesContract manufacturer0000api.fda.gov
Shun Hsiang Plastic Co.,ltd.Taoyuan, TaiwanContract manufacturer0000api.fda.gov
Space Maintainers LabChatsworth, CA, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Stelray Plastic Products, IncAnsonia, CT, United StatesContract manufacturer0000api.fda.gov
Slow Wave, Inc.Lakeway, TX, United StatesManufacturer0000api.fda.gov
Zepeda Dental LabOglesby, IL, United StatesContract manufacturer0000api.fda.gov

Updated October 20, 2026. 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.