Updated 22 October 2026
Dental device distributors in the United States: 1,354 licensed establishments
The Bastion Hale Distributor Index lists 1,354 establishments in the United States whose registry records include dental: 634 with a channel role (importer, distributor, wholesaler or authorised representative), 80 registration holders without a channel role, and 640 registered as manufacturer or exporter only, out of 9,881 medical device establishments in the United States overall. The records come from US FDA (openFDA) and Health Canada, last seen on 22 October 2026.
Dental covers equipment, implants, consumables and intraoral imaging sold to clinics and laboratories rather than hospitals. Dental dealers are a separate channel from hospital distributors, with their own wholesalers and trade shows. The segment usually has many establishments with small registration counts each.
By role
| Role | Establishments | Share | What it means |
|---|---|---|---|
| Importer | 610 | 45% | Named as importer in a registry: EUDAMED importer, FDA initial importer, or a Gulf import licence. |
| Distributor | 79 | 6% | Holds a distribution licence or is listed as distributor (Health Canada MDEL, SFDA, Oman MOH). |
| Registration holder | 201 | 15% | Holds device licences or registrations in its own name (Health Canada MDALL licence holder). |
| Manufacturer | 1,312 | 97% | Registered as a manufacturer with an address in this market, including foreign registrations. |
| Exporter | 67 | 5% | Registered with the US FDA as an exporter of devices made for export. |
An establishment can hold several roles, so the shares add to more than 100%.
Who holds the registration in the United States
In the United States the manufacturer registers its own establishment with the FDA and lists its devices; there is no local holder requirement. A US importer must also register as an initial importer, and the 510(k) or PMA stays in the manufacturer's name, so a distributor can be replaced without losing market access.
Top 20 dental establishments by size
Channel roles first, then registration holders, then manufacturers. Size is a 0 to 100 score; Complete is 0 to 5.
| # | Establishment | Roles | Segments | Products | Registrations | Principals | Size | Complete |
|---|---|---|---|---|---|---|---|---|
| 1 | ZIMMER, INC. WARSAW, IN | Channel Importer, Registration holder, Manufacturer, Exporter | Anaesthesia and respiratory, General hospital and consumables, Dental +5 more | 1316 | 240 | 0 | 78.2 | 3/5 |
| 2 | MEDTRONIC SOFAMOR DANEK USA, INC. Memphis, TN | Channel Importer, Registration holder, Manufacturer, Exporter | Aesthetics, dermatology and lasers, Cardiovascular, General hospital and consumables +9 more | 831 | 109 | 1 | 77.0 | 4/5 |
| 3 | COOK, INCORPORATED ELLETTSVILLE, IN | Channel Importer, Registration holder, Manufacturer, Exporter | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +9 more | 791 | 150 | 0 | 75.6 | 3/5 |
| 4 | Teleflex Medical Inc. Morrisville, NC | Channel Importer, Registration holder, Manufacturer | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +9 more | 858 | 99 | 1 | 75.5 | 4/5 |
| 5 | Bausch & Lomb Incorporated Manchester, MO | Channel Importer, Registration holder, Manufacturer, Exporter | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +9 more | 637 | 139 | 0 | 74.2 | 3/5 |
| 6 | Microgenics Corporation Fremont, CA | Channel Importer, Registration holder, Manufacturer, Exporter | Cardiovascular, Dental, Ear, nose and throat +1 more | 298 | 173 | 1 | 74.0 | 4/5 |
| 7 | DEPUY ORTHOPAEDICS, INC. RAYNHAM, MA | Channel Importer, Registration holder, Manufacturer, Exporter | Anaesthesia and respiratory, General hospital and consumables, Dental +8 more | 773 | 58 | 1 | 73.7 | 4/5 |
| 8 | Kerr Corporation ORANGE, CA | Channel Importer, Distributor, Registration holder, Manufacturer | Aesthetics, dermatology and lasers, Anaesthesia and respiratory, General hospital and consumables +3 more | 504 | 92 | 1 | 73.7 | 4/5 |
| 9 | ASPEN SURGICAL PRODUCTS, INC. Caledonia, MI | Channel Importer, Registration holder, Manufacturer | Aesthetics, dermatology and lasers, Anaesthesia and respiratory, Cardiovascular +10 more | 767 | 96 | 0 | 72.2 | 3/5 |
| 10 | KLS-Martin L.P. Jacksonville, FL | Channel Importer, Distributor, Registration holder, Manufacturer | Cardiovascular, General hospital and consumables, Dental +7 more | 561 | 52 | 1 | 71.6 | 4/5 |
| 11 | ORTHO ORGANIZERS, INC. Savannah, GA | Channel Importer, Distributor, Registration holder, Manufacturer | General hospital and consumables, Dental, Imaging, radiology and radiotherapy +1 more | 691 | 66 | 0 | 71.1 | 3/5 |
| 12 | MICROPORT ORTHOPEDICS INC. Arlington, TN | Channel Importer, Registration holder, Manufacturer, Exporter | General hospital and consumables, Dental, Gastroenterology, urology and OB/GYN +3 more | 645 | 59 | 0 | 70.3 | 3/5 |
| 13 | DeRoyal Industries, Inc. NEW TAZEWELL, TN | Channel Importer, Registration holder, Manufacturer | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +9 more | 1991 | 46 | 0 | 70.1 | 3/5 |
| 14 | GC AMERICA INC. ALSIP, IL | Channel Importer, Distributor, Registration holder, Manufacturer | General hospital and consumables, Dental, Orthopaedics, spine and trauma | 466 | 79 | 0 | 70.0 | 3/5 |
| 15 | ZIMVIE US CORP LLC. Palm Beach Gardens, FL | Channel Importer, Distributor, Registration holder, Manufacturer, Exporter | Dental, Orthopaedics, spine and trauma, Surgery and endoscopy | 450 | 67 | 0 | 70.0 | 3/5 |
| 16 | STERIS CORPORATION Breckenridge Hills, MO | Channel Importer, Registration holder, Manufacturer, Exporter | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +9 more | 591 | 40 | 0 | 68.0 | 3/5 |
| 17 | Avanos Medical, Inc. Alpharetta, GA | Channel Importer, Distributor, Registration holder, Manufacturer | Aesthetics, dermatology and lasers, Anaesthesia and respiratory, Cardiovascular +9 more | 245 | 85 | 0 | 67.1 | 3/5 |
| 18 | COOPERSURGICAL, INC. Trumbull, CT | Channel Importer, Distributor, Registration holder, Manufacturer | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +7 more | 250 | 76 | 0 | 66.6 | 3/5 |
| 19 | INTEGRA LIFESCIENCES CORPORATION PLAINSBORO, NJ | Channel Importer, Registration holder, Manufacturer, Exporter | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +9 more | 945 | 17 | 0 | 66.5 | 3/5 |
| 20 | PATTERSON DENTAL SUPPLY, INC. ST. PAUL, MN | Channel Importer, Registration holder, Manufacturer | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +8 more | 199 | 64 | 1 | 66.1 | 4/5 |
Questions about dental distributors in the United States
How many dental distributors are there in the United States?
The Index counts 1,354 establishments in the United States with dental in their registry record, of which 634 hold a channel role as importer, distributor, wholesaler or authorised representative. The number comes from US FDA (openFDA) and Health Canada and was last refreshed on 22 October 2026.
Who can hold a dental device registration in the United States?
In the United States the manufacturer registers its own establishment with the FDA and lists its devices; there is no local holder requirement. A US importer must also register as an initial importer, and the 510(k) or PMA stays in the manufacturer's name, so a distributor can be replaced without losing market access.
How do I find a dental distributor in the United States?
Open the top establishments on this page and check their roles, principals and registration counts. Then search the Index for your device and the United States to reveal three profiles. For a ranked shortlist for your device, get the Next 10 Markets report.
What does the Distributor Index count as a dental distributor in the United States?
A company that appears in a public regulatory registry with an address in the United States and whose linked device listings fall in the dental segment, in any of the roles importer, distributor, wholesaler, authorised representative, registration holder, manufacturer or exporter. Each company is counted once.
Other segments in the United States
Dental in other North America markets
Sources
- US FDA Establishment Registration and Device Listing, openFDA bulk download: 1,323 establishments, last seen 22 October 2026. US government work, public domain.
- Health Canada MDALL active licence listing and MDEL establishment licence listing: 250 establishments, last seen 22 October 2026. Contains information licensed under the Open Government Licence, Canada.
Index build 22 October 2026. Each establishment is counted once per country after resolving names across sources. Named individuals are never collected.
Registry data. Bastion Hale does not vouch for any establishment.