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.
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- Device
- Positioner, Tooth, Preformed
- Product code
- KMY
- Country
- United States
Makers of Positioner, Tooth, Preformed in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Jumar Corporation | Bainbridge Is, WA, United States | Manufacturer | 1 | August 12, 1983 | 0 | 0 | 0 | api.fda.gov |
| TP Orthodontics, Inc. | La Porte, IN, United States | Manufacturer | 1 | June 28, 1978 | 0 | 0 | 0 | api.fda.gov |
| Airway Management Inc. | Farmers Branch, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Alta Smiles, LLC | Fort Washington, PA, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| American Orthodontics | Sheboygan, WI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aurum Ceramic Dental Laboratories LLC | Spokane, WA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Allesee Orthodontic Appliances, Inc. | Sturtevant, WI, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Buffalo Dental MFG. Co., Inc. | Syosset, NY, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Buffalo Dental Mfg Co Inc | Hancock, NY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Burbank Dental Laboratory | Burbank, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ClearCorrect, LLC | Round Rock, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dentsply Sirona Orthodontics Inc. | Sarasota, FL, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dentsply Sirona Orthodontics Inc. | Richardson, TX, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Five Star Orthodontic Laboratory & Supply, Inc. | Denton, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Formlabs Inc. | Somerville, MA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Formlabs Ohio, Inc. | Millbury, OH, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GC Orthodontics America Inc. | Alsip, IL, United States | Complaint file establishment, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Great Lakes Dental Technologies, Ltd. | Tonawanda, NY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hiossen, Inc. | Morrisville, PA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jamesb Dental Studio | Dumont, NJ, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Keystone Industries | Myerstown, PA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Keystone Industries | Cherry Hill, NJ, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Keystone Industries - Gibbstown | Gibbstown, NJ, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Luxcreo Inc. | Chicago, IL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ortho Dental Lab, LLC | Antioch, TN, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ortho Organizers, Inc. | Savannah, GA, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ortho Solutions LC | Lake Saint Louis, MO, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pac-Dent Inc. | Brea, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Prismatik Dentalcraft, Inc. | Irvine, CA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Somnomed Inc. | Plano, TX, United States | Complaint file establishment, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sprintray Inc. | Los Angeles, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sprintray Inc. | Huntington Beach, CA, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Suncoast Dental, Inc. | Clearwater, FL, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sweetguard Inc | City of Industry, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| The Argen Corporation | San Diego, CA, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vivos Therapeutics INC. | Murray, KY, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Whip-Mix Corp. | Louisville, KY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.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.