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Data / Medical devices / Mouthguard, Over-The-Counter / United States

FDA-registered makers of Mouthguard, Over-The-Counter in the United States: 22 establishments

22 establishments in the United States are registered with the FDA to make Mouthguard, Over-The-Counter (product code OBR). 16 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 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, Over-The-Counter
Product code
OBR
Country
United States

Makers of Mouthguard, Over-The-Counter in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Medtech Products, Inc.Tarrytown, NY, United StatesComplaint file establishment, Specification developer8December 22, 2020000api.fda.gov
DenTek Oral Care, Inc.Tarrytown, NY, United StatesSpecification developer7December 22, 2020000api.fda.gov
Doc Brands, Inc.Knoxville, TN, United StatesComplaint file establishment, Repackager or relabeler, Specification developer3May 19, 2025000api.fda.gov
Ranir LLCGrand Rapids, MI, United StatesComplaint file establishment, Manufacturer, Specification developer2December 20, 2013000api.fda.gov
Advantage Dental Products, Inc.Clarkston, MI, United StatesManufacturer1January 23, 2014000api.fda.gov
Akervall TechnologiesSaline, MI, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler1October 15, 2012000api.fda.gov
Archtek, Inc.Carmel, IN, United StatesSpecification developer1February 8, 2008000api.fda.gov
Boyd ResearchSt Pete Beach, FL, United StatesManufacturer1September 17, 2021000api.fda.gov
Clear ClubInglewood, CA, United StatesManufacturer1November 18, 2022000api.fda.gov
Dental Choice Holdings LLCLouisville, KY, United StatesSpecification developer1August 23, 2019000api.fda.gov
Encore LaboratorySanta Ana, CA, United StatesManufacturer1November 25, 2025000api.fda.gov
Grindguard IncSan Francisco, CA, United StatesManufacturer1October 17, 2025000api.fda.gov
Koncept Innovators, LLCMyrtle Beach, SC, United StatesSpecification developer1January 18, 2019000api.fda.gov
Owl DentalSan Leandro, CA, United StatesManufacturer1February 26, 2026000api.fda.gov
OraLabs, Inc.Parker, CO, United StatesSpecification developer1June 27, 2012000api.fda.gov
Reazeal CorpWilmington, DE, United StatesManufacturer, Specification developer1November 6, 2023000api.fda.gov
Midwest TekNew Albany, IN, United StatesContract manufacturer0000api.fda.gov
Moldgenix LLCTrumbauersville, PA, United StatesContract manufacturer0000api.fda.gov
Randmark Dental Products, LLCLusby, MD, United StatesSpecification developer0000api.fda.gov
Sentinel MouthguardsSaint Petersburg, FL, United StatesManufacturer0000api.fda.gov
Smartguard RX IncLayton, UT, United StatesSpecification developer0000api.fda.gov
Stelray Plastic Products, IncAnsonia, CT, United StatesContract manufacturer0000api.fda.gov

Updated November 2, 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.