Skip to the page

Data / Medical devices / Positioner, Tooth, Preformed / United States

FDA-registered makers of Positioner, Tooth, Preformed in the United States: 37 establishments

37 establishments in the United States are registered with the FDA to make Positioner, Tooth, Preformed (product code KMY). 2 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.

Device
Positioner, Tooth, Preformed
Product code
KMY
Country
United States

Makers of Positioner, Tooth, Preformed in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Jumar CorporationBainbridge Is, WA, United StatesManufacturer1August 12, 1983000api.fda.gov
TP Orthodontics, Inc.La Porte, IN, United StatesManufacturer1June 28, 1978000api.fda.gov
Airway Management Inc.Farmers Branch, TX, United StatesManufacturer0000api.fda.gov
Alta Smiles, LLCFort Washington, PA, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
American OrthodonticsSheboygan, WI, United StatesManufacturer0000api.fda.gov
Aurum Ceramic Dental Laboratories LLCSpokane, WA, United StatesManufacturer0000api.fda.gov
Allesee Orthodontic Appliances, Inc.Sturtevant, WI, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Buffalo Dental MFG. Co., Inc.Syosset, NY, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Buffalo Dental Mfg Co IncHancock, NY, United StatesManufacturer0000api.fda.gov
Burbank Dental LaboratoryBurbank, CA, United StatesManufacturer0000api.fda.gov
ClearCorrect, LLCRound Rock, TX, United StatesManufacturer0000api.fda.gov
Dentsply Sirona Orthodontics Inc.Sarasota, FL, United StatesManufacturer, Specification developer0000api.fda.gov
Dentsply Sirona Orthodontics Inc.Richardson, TX, United StatesSpecification developer0000api.fda.gov
Five Star Orthodontic Laboratory & Supply, Inc.Denton, TX, United StatesManufacturer0000api.fda.gov
Formlabs Inc.Somerville, MA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Formlabs Ohio, Inc.Millbury, OH, United StatesManufacturer0000api.fda.gov
GC Orthodontics America Inc.Alsip, IL, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler0000api.fda.gov
Great Lakes Dental Technologies, Ltd.Tonawanda, NY, United StatesManufacturer0000api.fda.gov
Hiossen, Inc.Morrisville, PA, United StatesManufacturer0000api.fda.gov
Jamesb Dental StudioDumont, NJ, United StatesManufacturer0000api.fda.gov
Keystone IndustriesMyerstown, PA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Keystone IndustriesCherry Hill, NJ, United StatesManufacturer0000api.fda.gov
Keystone Industries - GibbstownGibbstown, NJ, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Luxcreo Inc.Chicago, IL, United StatesSpecification developer0000api.fda.gov
Ortho Dental Lab, LLCAntioch, TN, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Ortho Organizers, Inc.Savannah, GA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Ortho Solutions LCLake Saint Louis, MO, United StatesManufacturer0000api.fda.gov
Pac-Dent Inc.Brea, CA, United StatesManufacturer0000api.fda.gov
Prismatik Dentalcraft, Inc.Irvine, CA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Somnomed Inc.Plano, TX, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler0000api.fda.gov
Sprintray Inc.Los Angeles, CA, United StatesManufacturer0000api.fda.gov
Sprintray Inc.Huntington Beach, CA, United StatesManufacturer, Specification developer0000api.fda.gov
Suncoast Dental, Inc.Clearwater, FL, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Sweetguard IncCity of Industry, CA, United StatesManufacturer0000api.fda.gov
The Argen CorporationSan Diego, CA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Vivos Therapeutics INC.Murray, KY, United StatesSpecification developer0000api.fda.gov
Whip-Mix Corp.Louisville, KY, United StatesManufacturer0000api.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.