Updated 22 October 2026
Dental device distributors in the United States: 1,355 licensed establishments
The Bastion Hale Distributor Index lists 1,355 establishments in the United States whose registry records include dental: 13 independent distributors (a channel role such as importer, distributor, wholesaler or authorised representative, and no manufacturing of their own), 621 manufacturers' own import or sales entities, 0 regulatory representatives, and 721 manufacturers or exporters, out of 10,187 medical device establishments in the United States overall. The records come from US FDA (openFDA), Health Canada and MHRA UK, last seen on 23 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 | 1,313 | 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 13 independent dental distributors
Independent distributors only, ranked by the other manufacturers' lines they carry, then registrations held, then size.
| # | Establishment | Roles | Segments | Products | Registrations | Principals | Size | Complete |
|---|---|---|---|---|---|---|---|---|
| 1 | InfuSystem Inc. Lenexa, KS | Distributor Importer, Distributor | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +2 more | 26 | 2 | 0 | 37.2 | 3/5 |
| 2 | MAXMORESPINE San Diego, CA | Distributor Importer | Anaesthesia and respiratory, General hospital and consumables, Dental +3 more | 36 | 1 | 0 | 31.2 | 3/5 |
| 3 | anax USA Ardmore, OK | Distributor Importer | Dental | 11 | 1 | 1 | 28.2 | 4/5 |
| 4 | GRAVITIQ LLC New York, NY | Distributor Importer | General hospital and consumables, Dental, Gastroenterology, urology and OB/GYN +2 more | 18 | 1 | 0 | 27.9 | 3/5 |
| 5 | JACK JACK LLC Miami, FL | Distributor Importer | General hospital and consumables, Dental, Gastroenterology, urology and OB/GYN +2 more | 18 | 1 | 0 | 27.9 | 3/5 |
| 6 | FOREO INC Las Vegas, NV | Distributor Importer | Aesthetics, dermatology and lasers, Dental, Patient monitoring and neurology +1 more | 13 | 1 | 0 | 26.3 | 3/5 |
| 7 | DENTALINE LLC Brooklyn, NY | Distributor Importer | Dental | 10 | 1 | 0 | 25.1 | 3/5 |
| 8 | RESPLABS MEDICAL USA INC. Tucson, AZ | Distributor Importer | Anaesthesia and respiratory, General hospital and consumables, Dental | 8 | 1 | 0 | 24.1 | 3/5 |
| 9 | YUCERA HEALTHCARE TECH USA INC Ontario, CA | Distributor Importer | Dental | 3 | 1 | 0 | 20.0 | 3/5 |
| 10 | BIOABUTMENT INC. Irvine, CA | Distributor Importer | Dental | 2 | 1 | 0 | 18.5 | 3/5 |
| 11 | ORAVANCE WELLNESS LLC. Westport, CT | Distributor Importer | Dental | 2 | 1 | 0 | 18.5 | 3/5 |
| 12 | XTECHDENTAL INC Fort Lee, NJ | Distributor Importer | Dental, Imaging, radiology and radiotherapy | 2 | 1 | 0 | 18.5 | 3/5 |
| 13 | XRD DENTAL EQUIPMENT Clermont, FL | Distributor Importer | Dental | 1 | 1 | 0 | 16.5 | 3/5 |
Include manufacturers, their own sales entities and regulatory representatives (1,342)
Manufacturers, companies that are a manufacturer's own import or sales arm, and regulatory representatives (authorised representatives, sponsors or registration holders with no import or distribution role). They are registered here but are not independent distributors.
| # | Establishment | Roles | Segments | Products | Registrations | Principals | Size | Complete |
|---|---|---|---|---|---|---|---|---|
| 1 | ZIMMER, INC. WARSAW, IN | Maker's own entity Importer, Registration holder, Manufacturer, Exporter | Anaesthesia and respiratory, General hospital and consumables, Dental +5 more | 1316 | 249 | 0 | 80.6 | 3/5 |
| 2 | Microgenics Corporation Fremont, CA | Maker's own entity Importer, Registration holder, Manufacturer, Exporter | Cardiovascular, Dental, Ear, nose and throat +1 more | 298 | 204 | 1 | 77.1 | 4/5 |
| 3 | COOK, INCORPORATED ELLETTSVILLE, IN | Maker's own entity Importer, Registration holder, Manufacturer, Exporter | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +9 more | 791 | 202 | 0 | 79.4 | 3/5 |
| 4 | Bausch & Lomb Incorporated Manchester, MO | Maker's own entity Importer, Registration holder, Manufacturer, Exporter | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +9 more | 637 | 151 | 0 | 77.0 | 3/5 |
| 5 | Teleflex Medical Inc. Morrisville, NC | Maker's own entity Importer, Registration holder, Manufacturer | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +9 more | 858 | 114 | 1 | 78.6 | 4/5 |
| 6 | ASPEN SURGICAL PRODUCTS, INC. Caledonia, MI | Maker's own entity Importer, Registration holder, Manufacturer | Aesthetics, dermatology and lasers, Anaesthesia and respiratory, Cardiovascular +10 more | 767 | 113 | 0 | 75.3 | 3/5 |
| 7 | MICROPORT ORTHOPEDICS INC. Arlington, TN | Maker's own entity Importer, Registration holder, Manufacturer, Exporter | General hospital and consumables, Dental, Gastroenterology, urology and OB/GYN +3 more | 645 | 111 | 0 | 75.6 | 3/5 |
| 8 | MEDTRONIC SOFAMOR DANEK USA, INC. Memphis, TN | Maker's own entity Importer, Registration holder, Manufacturer, Exporter | Aesthetics, dermatology and lasers, Cardiovascular, General hospital and consumables +9 more | 831 | 109 | 1 | 77.0 | 4/5 |
| 9 | Avanos Medical, Inc. Alpharetta, GA | Maker's own entity Importer, Distributor, Registration holder, Manufacturer | Aesthetics, dermatology and lasers, Anaesthesia and respiratory, Cardiovascular +9 more | 245 | 104 | 0 | 70.4 | 3/5 |
| 10 | COOPERSURGICAL, INC. Trumbull, CT | Maker's own entity Importer, Distributor, Registration holder, Manufacturer | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +7 more | 250 | 103 | 0 | 70.5 | 3/5 |
| 11 | Kerr Corporation ORANGE, CA | Maker's own entity 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 |
| 12 | GC AMERICA INC. ALSIP, IL | Maker's own entity Importer, Distributor, Registration holder, Manufacturer | General hospital and consumables, Dental, Orthopaedics, spine and trauma | 466 | 79 | 0 | 70.0 | 3/5 |
| 13 | ORTHO ORGANIZERS, INC. Savannah, GA | Maker's own entity Importer, Distributor, Registration holder, Manufacturer | General hospital and consumables, Dental, Imaging, radiology and radiotherapy +1 more | 691 | 69 | 0 | 73.7 | 3/5 |
| 14 | ZIMVIE US CORP LLC. Palm Beach Gardens, FL | Maker's own entity Importer, Distributor, Registration holder, Manufacturer, Exporter | Dental, Orthopaedics, spine and trauma, Surgery and endoscopy | 450 | 68 | 0 | 72.5 | 3/5 |
| 15 | PATTERSON DENTAL SUPPLY, INC. ST. PAUL, MN | Maker's own entity Importer, Registration holder, Manufacturer | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +8 more | 199 | 64 | 1 | 66.1 | 4/5 |
| 16 | DEPUY ORTHOPAEDICS, INC. RAYNHAM, MA | Maker's own entity Importer, Registration holder, Manufacturer, Exporter | Anaesthesia and respiratory, General hospital and consumables, Dental +8 more | 773 | 62 | 1 | 76.5 | 4/5 |
| 17 | PETER BRASSELER HOLDINGS, LLC ALSO TRADING AS BRASSELER U.S.A. DENTAL, LLC Savannah, GA | Maker's own entity Distributor, Registration holder, Manufacturer | Aesthetics, dermatology and lasers, General hospital and consumables, Dental +1 more | 201 | 55 | 0 | 59.4 | 3/5 |
| 18 | KLS-Martin L.P. Jacksonville, FL | Maker's own entity Importer, Distributor, Registration holder, Manufacturer | Cardiovascular, General hospital and consumables, Dental +7 more | 561 | 52 | 1 | 71.6 | 4/5 |
| 19 | ORMCO CORPORATION ALSO TRADING AS SYBRONENDO Brea, CA | Maker's own entity Distributor, Registration holder, Manufacturer | General hospital and consumables, Dental | 192 | 51 | 0 | 58.8 | 3/5 |
| 20 | ACUMED, LLC Hillsboro, OR | Maker's own entity Importer, Registration holder, Manufacturer | General hospital and consumables, Dental, Patient monitoring and neurology +3 more | 456 | 47 | 0 | 68.6 | 3/5 |
Questions about dental distributors in the United States
How many dental distributors are there in the United States?
The Index counts 1,355 establishments in the United States with dental in their registry record, of which 13 are independent distributors (a channel role and no manufacturing of their own). The number comes from US FDA (openFDA), Health Canada and MHRA UK 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 23 October 2026. US government work, public domain.
- Health Canada MDALL active licence listing and MDEL establishment licence listing: 250 establishments, last seen 23 October 2026. Contains information licensed under the Open Government Licence, Canada.
- UK MHRA Public Access Registration Database (PARD): 174 establishments, last seen 23 October 2026. Public register.
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.