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Data / Medical devices / Mouthguard, Prescription / United States

FDA-registered makers of Mouthguard, Prescription in the United States: 41 establishments

41 establishments in the United States are registered with the FDA to make Mouthguard, Prescription (product code MQC). 30 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 3, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

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Device
Mouthguard, Prescription
Product code
MQC
Country
United States

Makers of Mouthguard, Prescription in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Burbank Dental LaboratoryBurbank, CA, United StatesManufacturer2April 9, 2021000api.fda.gov
Formlabs Inc.Somerville, MA, United StatesComplaint file establishment, Specification developer2February 16, 2024000api.fda.gov
Formlabs Ohio, Inc.Millbury, OH, United StatesManufacturer2February 16, 2024000api.fda.gov
Keystone IndustriesMyerstown, PA, United StatesManufacturer2April 9, 2021000api.fda.gov
Keystone IndustriesCherry Hill, NJ, United StatesManufacturer2April 9, 2021000api.fda.gov
Keystone Industries - GibbstownGibbstown, NJ, United StatesComplaint file establishment, Manufacturer2April 9, 2021010api.fda.gov
Whip-Mix Corp.Louisville, KY, United StatesManufacturer2March 18, 2025000api.fda.gov
3D Diagnostix IncAllston, MA, United StatesManufacturer1November 25, 2020000api.fda.gov
Archtek, Inc.Carmel, IN, United StatesSpecification developer1October 14, 2009000api.fda.gov
Davis Dental LabWyoming, MI, United StatesManufacturer1March 18, 2003000api.fda.gov
Dentsply Sirona Orthodontics Inc.Sarasota, FL, United StatesManufacturer, Specification developer1November 27, 2006000api.fda.gov
Encore LaboratorySanta Ana, CA, United StatesManufacturer1August 22, 2024000api.fda.gov
Grindguard IncSan Francisco, CA, United StatesManufacturer1February 10, 2025000api.fda.gov
Great Lakes Dental Technologies, Ltd.Tonawanda, NY, United StatesManufacturer1January 18, 2024000api.fda.gov
Late Night Concepts Inc. (dba Brux Night Guard)Canoga Park, CA, United StatesManufacturer1April 11, 2019000api.fda.gov
Luxcreo Inc.Chicago, IL, United StatesSpecification developer1January 18, 2024000api.fda.gov
Medtech Products, Inc.Tarrytown, NY, United StatesComplaint file establishment, Specification developer1March 3, 2006000api.fda.gov
Myohealth Technologies, LLCPortland, OR, United StatesManufacturer1February 2, 2024000api.fda.gov
Pac-Dent Inc.Brea, CA, United StatesManufacturer1March 26, 2024000api.fda.gov
Prismatik Dentalcraft, Inc.Irvine, CA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler1February 17, 2023000api.fda.gov
Randmark Dental Products, LLCLusby, MD, United StatesSpecification developer1August 5, 2011000api.fda.gov
Remvia, LLCSaint Louis, MO, United StatesComplaint file establishment, Manufacturer, Specification developer1December 5, 2025000api.fda.gov
Smartguard RX IncLayton, UT, United StatesSpecification developer1March 14, 2013000api.fda.gov
Somnomed Inc.Plano, TX, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler1December 13, 2011000api.fda.gov
Sprintray Inc.Los Angeles, CA, United StatesManufacturer1November 12, 2021000api.fda.gov
Sprintray Inc.Huntington Beach, CA, United StatesManufacturer, Specification developer1November 12, 2021000api.fda.gov
Serena SleepHudson, WI, United StatesManufacturer1October 13, 2023000api.fda.gov
Slow Wave, Inc.Lakeway, TX, United StatesManufacturer1June 4, 2024000api.fda.gov
TMJ Services LLCFranklin, TN, United StatesManufacturer1September 25, 2017000api.fda.gov
Vivos Therapeutics INC.Murray, KY, United StatesSpecification developer1July 17, 2019000api.fda.gov
3DPX MedicalChicago, IL, United StatesContract manufacturer0000api.fda.gov
Boyd ResearchSt Pete Beach, FL, United StatesManufacturer0000api.fda.gov
Dental Plus Usa, LLCSouth Jordan, UT, United StatesRepackager or relabeler, Reprocessor0000api.fda.gov
Dentsply LLCMilford, DE, United StatesManufacturer0000api.fda.gov
Imagine Milling Technologies, LLCChantilly, VA, United StatesRemanufacturer, Repackager or relabeler0000api.fda.gov
Ortho Organizers, Inc.Savannah, GA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Owl DentalSan Leandro, CA, United StatesManufacturer0000api.fda.gov
Oral Arts Laboratory, Inc.Huntsville, AL, United StatesContract manufacturer0000api.fda.gov
Stelray Plastic Products, IncAnsonia, CT, United StatesContract manufacturer0000api.fda.gov
Thermoplastic Comfort Systems, Inc.Signal Hill, CA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Truer Medical, Inc.Orange, CA, United StatesContract manufacturer0000api.fda.gov

Updated November 3, 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.