Data / Medical devices / Wax, Dental, Intraoral / United States
FDA-registered makers of Wax, Dental, Intraoral in the United States: 37 establishments
37 establishments in the United States are registered with the FDA to make Wax, Dental, Intraoral (product code EGD). 2 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 3, 2026.
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- Device
- Wax, Dental, Intraoral
- Product code
- EGD
- Country
- United States
Makers of Wax, Dental, Intraoral in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Garreco, LLC | Heber Springs, AR, United States | Manufacturer | 7 | August 21, 1991 | 0 | 0 | 0 | api.fda.gov |
| Kulzer, LLC | South Bend, IN, United States | Contract manufacturer, Manufacturer | 2 | November 17, 1992 | 0 | 0 | 0 | api.fda.gov |
| Advanced Dental Designs | Moreno Valley, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| American Orthodontics | Sheboygan, WI, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Asap LLC | Santa Fe Spgs, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ashtel Studios, Inc. | Ontario, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bisco, Inc. | Schaumburg, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Coltene/Whaledent Inc. | Cuyahoga Falls, OH, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DenTek Oral Care, Inc. | Tarrytown, NY, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Freeman Manufacturing & Supply Co. | Avon, OH, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GC Orthodontics America Inc. | Alsip, IL, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gurunanda LLC | Buena Park, CA, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Great Lakes Dental Technologies, Ltd. | Tonawanda, NY, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hager Worldwide, Inc. | Hickory, NC, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Integra LifeSciences Production Corporation | Mansfield, MA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ivoclar Vivadent Manufacturing, Inc | Somerset, NJ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kent Manufacturing Company | Grand Rapids, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kerr Corporation | Pomona, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Keystone Industries | Myerstown, PA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medtech Products, Inc. | Tarrytown, NY, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Memphis Dental MFG. Co., Inc. | Memphis, TN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| O&S Dental, Inc. | Chicago, IL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ortho Organizers, Inc. | Savannah, GA, United States | Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orvance, LLC | Caledonia, MI, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ormco Corporation | Brea, CA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pac-Dent Inc. | Brea, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Prime Dental Manufacturing, Inc. | Chicago, IL, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ranir LLC | Grand Rapids, MI, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Reko Dental, LLC | Gardena, CA, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Reliance Orthodontic Products, Inc. | Itasca, IL, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rosemarie Products Company, LLC | Mason, OH, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sagemax Bioceramics, Inc. | Federal Way, WA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ST. George Technology, Inc. | Wilmington, NC, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sunstar Americas, Inc. | Schaumburg, IL, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Solventum Orthodontics Corporation | Monrovia, CA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sonrisa/Easy Denture/NSI | Wilmington, NC, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ultradent Products Inc. | South Jordan, UT, United States | Manufacturer | 0 | 0 | 0 | 0 | api.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.