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
| Country | Makers |
|---|---|
| United States | 66 |
| China | 8 |
| Canada | 3 |
| Australia | 2 |
| France | 2 |
| Germany | 2 |
| India | 2 |
| Philippines | 1 |
| Hong Kong | 1 |
| Spain | 1 |
| New Zealand | 1 |
| Switzerland | 1 |
| South Korea | 1 |
| Trinidad and Tobago | 1 |
| Thailand | 1 |
| Costa Rica | 1 |
| Taiwan | 1 |
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.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Ortho Solutions LC | Lake Saint Louis, MO, United States | Contract manufacturer, Manufacturer | 8 | May 31, 2022 | 0 | 0 | 0 | api.fda.gov |
| Sleeping Well, LLC | Shelburne, VT, United States | Specification developer | 6 | June 15, 2022 | 0 | 0 | 0 | api.fda.gov |
| Somnomed Inc. | Plano, TX, United States | Complaint file establishment, Manufacturer, Repackager or relabeler | 6 | June 12, 2026 | 0 | 0 | 0 | api.fda.gov |
| Somnomed, Ltd. | CROWS NEST New South Wales, Australia | Specification developer | 6 | June 12, 2026 | 0 | 0 | 0 | api.fda.gov |
| SomnoMed Phillipines Inc. | Makati City National Capital Region, Philippines | Manufacturer | 6 | June 12, 2026 | 0 | 0 | 0 | api.fda.gov |
| Vivos Therapeutics INC. | Murray, KY, United States | Repackager or relabeler, Specification developer | 5 | December 30, 2022 | 0 | 0 | 0 | api.fda.gov |
| Airway Management Inc. | Farmers Branch, TX, United States | Complaint file establishment, Contract manufacturer, Manufacturer | 4 | September 11, 2025 | 0 | 0 | 0 | api.fda.gov |
| Always More Marketing Inc | Calabasas, CA, United States | Specification developer | 4 | January 24, 2019 | 0 | 0 | 0 | api.fda.gov |
| Open Airway Dental Solutions Australia Pty Ltd | Taringa Queensland, Australia | Manufacturer | 4 | August 29, 2019 | 0 | 0 | 0 | api.fda.gov |
| Apex Dental Sleep Lab | La Mesa, CA, United States | Contract manufacturer, Manufacturer, Repackager or relabeler | 3 | May 3, 2024 | 0 | 0 | 0 | api.fda.gov |
| Digital Dental Depot | zhuhai Guangdong, China | Exporter to the US, Manufacturer | 3 | June 11, 2026 | 0 | 0 | 0 | api.fda.gov |
| Digital Dental Depot Limited | Hong Kong, Hong Kong | Exporter to the US, Manufacturer | 3 | June 11, 2026 | 0 | 0 | 0 | api.fda.gov |
| Fissiontech LLC | New York, NY, United States | Manufacturer | 3 | October 29, 2025 | 0 | 0 | 0 | api.fda.gov |
| Prismatik Dentalcraft, Inc. | Irvine, CA, United States | Complaint file establishment, Contract manufacturer, Manufacturer | 3 | November 14, 2023 | 0 | 1 | 0 | api.fda.gov |
| Prosomnus Sleep Technologies | Pleasanton, CA, United States | Complaint file establishment, Manufacturer | 3 | October 6, 2022 | 0 | 0 | 0 | api.fda.gov |
| Shenzhen Sany Pioneer Technology Co., Ltd. | Shenzhen Guangdong, China | Manufacturer | 3 | August 27, 2026 | 0 | 0 | 0 | api.fda.gov |
| Sleep Science Partners, Inc. | Larkspur, CA, United States | Specification developer | 3 | April 11, 2019 | 0 | 0 | 0 | api.fda.gov |
| American Sleep Dentistry | Cedar City, UT, United States | Manufacturer | 2 | June 8, 2017 | 0 | 0 | 0 | api.fda.gov |
| Apnea Sciences Corporation | Henderson, NV, United States | Manufacturer | 2 | August 18, 2017 | 0 | 0 | 0 | api.fda.gov |
| Crane Dental Laboratory | Rochester, NY, United States | Contract manufacturer, Manufacturer | 2 | September 17, 2019 | 0 | 0 | 0 | api.fda.gov |
| Doc Brands, Inc. | Knoxville, TN, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 2 | December 11, 2019 | 0 | 0 | 0 | api.fda.gov |
| Gergens Orthodontic Lab | Phoenix, AZ, United States | Contract manufacturer, Manufacturer | 2 | July 17, 2013 | 0 | 0 | 0 | api.fda.gov |
| Good Sleep Co Usa LLC | Grand Prairie, TX, United States | Manufacturer | 2 | October 24, 2025 | 0 | 0 | 0 | api.fda.gov |
| Great Lakes Dental Technologies, Ltd. | Tonawanda, NY, United States | Contract manufacturer, Manufacturer | 2 | March 20, 1996 | 0 | 0 | 0 | api.fda.gov |
| Koncept Innovators, LLC | Myrtle Beach, SC, United States | Specification developer | 2 | May 14, 2026 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Xomed, Inc. | Jacksonville, FL, United States | Manufacturer | 2 | January 10, 2013 | 0 | 1 | 0 | api.fda.gov |
| Oniris | RUEIL MALMAISON Hauts-de-Seine, France | Manufacturer | 2 | September 4, 2025 | 0 | 0 | 0 | api.fda.gov |
| Orthoapnea S.L. | Malaga, Spain | Manufacturer | 2 | February 25, 2021 | 0 | 0 | 0 | api.fda.gov |
| Panthera Dental Inc | Quebec City, Canada | Complaint file establishment, Manufacturer | 2 | February 22, 2018 | 0 | 0 | 0 | api.fda.gov |
| Shenzhen Kesite Digital Technology Co., Ltd. | Shenzhen Guangdong, China | Manufacturer | 2 | September 18, 2023 | 0 | 0 | 0 | api.fda.gov |
| The Snore Reliever Company | Largo, FL, United States | Repackager or relabeler, Specification developer | 2 | January 14, 2021 | 0 | 0 | 0 | api.fda.gov |
| True Function Laboratory Inc | La Mesa, CA, United States | Contract manufacturer, Manufacturer | 2 | February 11, 2019 | 0 | 0 | 0 | api.fda.gov |
| Tomed GmbH | Koeln North Rhine-Westphalia, Germany | Manufacturer | 2 | September 28, 2012 | 0 | 0 | 0 | api.fda.gov |
| Advanced Brain Monitoring, Inc. | Carlsbad, CA, United States | Manufacturer | 1 | July 22, 2011 | 0 | 0 | 0 | api.fda.gov |
| Advantech Plastics, LLC | Woodstock, IL, United States | Manufacturer | 1 | June 22, 2010 | 0 | 0 | 0 | api.fda.gov |
| Aiomega, LLC | Tyler, TX, United States | Manufacturer | 1 | November 6, 2025 | 0 | 0 | 0 | api.fda.gov |
| Apnomed, Inc. | Bellevue, WA, United States | Specification developer | 1 | November 21, 2018 | 0 | 0 | 0 | api.fda.gov |
| Boyd Research | St Pete Beach, FL, United States | Manufacturer | 1 | May 3, 2005 | 0 | 0 | 0 | api.fda.gov |
| Burbank Dental Laboratory | Burbank, CA, United States | Contract manufacturer, Manufacturer | 1 | May 3, 2024 | 0 | 0 | 0 | api.fda.gov |
| Diamond Orthotic Laboratory, LLC | La Mesa, CA, United States | Contract manufacturer, Manufacturer | 1 | September 3, 2020 | 0 | 0 | 0 | api.fda.gov |
| Dongguan Yiyao Science & Technology Development Co., Ltd. | Dongguan City Guangdong, China | Contract manufacturer, Manufacturer | 1 | October 3, 2025 | 0 | 0 | 0 | api.fda.gov |
| Ema-Sleep Inc | Bastrop, TX, United States | Specification developer | 1 | May 3, 2024 | 0 | 0 | 0 | api.fda.gov |
| Gelb Practice | Dix Hills, NY, United States | Specification developer | 1 | February 14, 2024 | 0 | 0 | 0 | api.fda.gov |
| Island Dental Lab Dba Emerald Dental Lab | Valley Stream, NY, United States | Manufacturer | 1 | May 10, 2023 | 0 | 0 | 0 | api.fda.gov |
| Innovative Health Technologies (NZ) Limited | Dunedin Otago, New Zealand | Manufacturer | 1 | December 21, 1999 | 0 | 0 | 0 | api.fda.gov |
| Keller Laboratories | Fenton, MO, United States | Contract manufacturer, Manufacturer | 1 | October 16, 2014 | 0 | 0 | 0 | api.fda.gov |
| MPOWRX HEALTH AND WELLNESS PRODUCTS 2012 Inc. | Calgary Alberta, Canada | Complaint file establishment, Specification developer | 1 | January 3, 2020 | 0 | 0 | 0 | api.fda.gov |
| Newsom | Paris, France | Manufacturer | 1 | December 15, 2016 | 0 | 0 | 0 | api.fda.gov |
| Oscimed SA | LA CHAUX-DE-FONDS, NE Neuchatel, Switzerland | Manufacturer | 1 | January 16, 2024 | 0 | 0 | 0 | api.fda.gov |
| QuietLab LLC | New York, NY, United States | Specification developer | 1 | December 5, 2025 | 0 | 0 | 0 | api.fda.gov |
| Ranir LLC | Grand Rapids, MI, United States | Complaint file establishment, Specification developer | 1 | September 8, 2010 | 0 | 0 | 0 | api.fda.gov |
| Reazeal Corp | Wilmington, DE, United States | Manufacturer | 1 | October 3, 2025 | 0 | 0 | 0 | api.fda.gov |
| Respironics Inc. | Murrysville, PA, United States | Complaint file establishment, Specification developer | 1 | February 6, 2004 | 0 | 0 | 0 | api.fda.gov |
| Shinrin-Yoku Traders LLC | Sherwood, OR, United States | Manufacturer | 1 | December 2, 2022 | 0 | 0 | 0 | api.fda.gov |
| Sicat GMBH & Co. KG | BONN North Rhine-Westphalia, Germany | Manufacturer | 1 | March 31, 2016 | 0 | 0 | 0 | api.fda.gov |
| Sleep Joy International LLC | Northport, NY, United States | Specification developer | 1 | August 18, 2010 | 0 | 0 | 0 | api.fda.gov |
| Smartguard RX Inc | Layton, UT, United States | Specification developer | 1 | August 23, 2021 | 0 | 0 | 0 | api.fda.gov |
| Solbaro Co.,ltd. | Eumseong Chungbuk, South Korea | Manufacturer | 1 | November 10, 2022 | 0 | 0 | 0 | api.fda.gov |
| Serena Sleep | Hudson, WI, United States | Manufacturer | 1 | March 10, 2021 | 0 | 0 | 0 | api.fda.gov |
| Splintek Inc. | Lenexa, KS, United States | Manufacturer | 1 | May 19, 2025 | 0 | 0 | 0 | api.fda.gov |
| The Metz Dental Laboratory | Gahanna, OH, United States | Manufacturer, Specification developer | 1 | April 5, 2013 | 0 | 0 | 0 | api.fda.gov |
| The Myerson Company Limited | Laventille San JuanLaventille, Trinidad and Tobago | Manufacturer, Specification developer | 1 | September 29, 1997 | 0 | 0 | 0 | api.fda.gov |
| Xiamen Yizhou Imp. & Exp. Co., Ltd. | Xiamen Fujian, China | Contract manufacturer, Exporter to the US | 1 | November 23, 2020 | 0 | 0 | 0 | api.fda.gov |
| Zhuhai DS Dental Technology Co., Ltd | Zhuhai Guangdong, China | Manufacturer | 1 | April 5, 2013 | 0 | 0 | 0 | api.fda.gov |
| 3DPX Medical | Chicago, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Artisan Laboratories Inc | Portland, OR, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aurum Ceramic Dental Laboratories Ltd. | CALGARY Alberta, Canada | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bialex Lab | Wichita Falls, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biotex, Inc. | Houston, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Comfort Acrylics, Inc. | Camas, WA, 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 | |
| Dongyang City Yonoel Outdoor Products Co.,ltd | Dongyang Zhejiang, China | Exporter to the US, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Drake Precision Dental Laboratory, Inc. | Charlotte, NC, United States | Contract 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 | |
| GCDL, LLC | Prospect Heights, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Global Dent Aids Private Limited | NOIDA Uttar Pradesh, India | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Green Dental Lab | Heber Springs, AR, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hexa Ceram Co., Ltd. | Sansai Chiang Mai, Thailand | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Idoc Dental Lab | Orange, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Inventex Medical | Niles, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ironwood Industries, Inc. | Libertyville, IL, United States | Contract 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 | |
| Laboratorios Dentales De Zona Franca, S.A. | Cartago, Costa Rica | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Life Science Outsourcing, Inc. | Brea, CA, United States | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| M R Utility Products Private Limited | Noida Uttar Pradesh, India | Contract manufacturer | 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 | |
| New Image Dental Laboratory, Inc. | Morrow, GA, United States | 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 | |
| R-Dent Dental Laboratory, Inc | Bartlett, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shun Hsiang Plastic Co.,ltd. | Taoyuan, Taiwan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Space Maintainers Lab | Chatsworth, CA, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stelray Plastic Products, Inc | Ansonia, CT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Slow Wave, Inc. | Lakeway, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zepeda Dental Lab | Oglesby, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.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.