Updated 22 October 2026
Dental device distributors in Spain: 26 licensed establishments
The Bastion Hale Distributor Index lists 26 establishments in Spain whose registry records include dental: 17 with a channel role (importer, distributor, wholesaler or authorised representative), 3 registration holders without a channel role, and 6 registered as manufacturer or exporter only, out of 1,855 medical device establishments in Spain overall. The records come from EUDAMED, US FDA (openFDA), Health Canada and web, 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 | 16 | 62% | Named as importer in a registry: EUDAMED importer, FDA initial importer, or a Gulf import licence. |
| Distributor | 2 | 8% | Holds a distribution licence or is listed as distributor (Health Canada MDEL, SFDA, Oman MOH). |
| Authorised representative | 3 | 12% | Represents a foreign manufacturer towards the regulator (EU authorised representative and similar). |
| Registration holder | 6 | 23% | Holds device licences or registrations in its own name (Health Canada MDALL licence holder). |
| Manufacturer | 20 | 77% | Registered as a manufacturer with an address in this market, including foreign registrations. |
| Exporter | 6 | 23% | 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 Spain
In the EU and EEA the manufacturer, or its EU authorised representative for manufacturers based outside the EU, registers in EUDAMED and holds the CE marking file. Importers and distributors register separately as economic operators and never own the registration, which is why EU channel changes are easier than elsewhere.
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 | B.T.I. BIOTECHNOLOGY INSTITUTE, S.L. Miñano | Channel Importer, Registration holder, Manufacturer, Exporter | Aesthetics, dermatology and lasers, Anaesthesia and respiratory, General hospital and consumables +6 more | 192 | 28 | 0 | 63.1 | 3/5 |
| 2 | AVINENT IMPLANT SYSTEM, S.L.U. Santpedor, Barcelona | Channel Importer, Distributor, Registration holder, Manufacturer | Aesthetics, dermatology and lasers, General hospital and consumables, Dental +1 more | 50 | 4 | 0 | 48.1 | 3/5 |
| 3 | Talladium España, S.L. Lleida | Channel Importer, Registration holder, Manufacturer | General hospital and consumables, Dental | 41 | 3 | 0 | 44.8 | 3/5 |
| 4 | ZimVie Spain S.L.U. Cornellá de Llobregat (Barcelona) | Channel Importer, Authorised representative, Manufacturer | Dental, Surgery and endoscopy | 84 | 1 | 0 | 42.7 | 4/5 |
| 5 | Ziacom Implants SLU Pinto | Channel Importer, Manufacturer, Exporter | Dental | 4 | 1 | 0 | 28.4 | 4/5 |
| 6 | MOZO GRAU SA VALLADOLID | Channel Importer, Manufacturer, Exporter | Dental | 3 | 1 | 0 | 27.2 | 3/5 |
| 7 | UNION DENTAL S.A. Tielmes | Channel Importer, Manufacturer | Dental, Ear, nose and throat | 4 | 1 | 0 | 26.7 | 4/5 |
| 8 | Valdent S.L. CASTELLÓN | Channel Importer, Authorised representative | Dental, Ear, nose and throat, Orthopaedics, spine and trauma +1 more | 0 | 0 | 18 | 26.6 | 4/5 |
| 9 | ZARC4ENDO GIJON Asturias(Autonomous Community) | Channel Distributor, Manufacturer | Dental | 8 | 1 | 0 | 26.3 | 3/5 |
| 10 | XPLORA 3D EUROPE, SL ARROYOMOLINOS (Madrid) | Channel Importer, Manufacturer | Dental | 3 | 1 | 0 | 25.6 | 3/5 |
| 11 | GMI Dental Implantology, S.L. Lleida | Channel Importer, Manufacturer | Dental | 2 | 1 | 0 | 24.2 | 4/5 |
| 12 | BIOSTAR LABORATORIOS SLU Madrid | Channel Importer, Manufacturer | Dental | 2 | 1 | 0 | 24.2 | 3/5 |
| 13 | ANCLADEN SL BARCELONA | Channel Importer | Dental, Ear, nose and throat, Orthopaedics, spine and trauma +1 more | 0 | 0 | 7 | 21.0 | 4/5 |
| 14 | Klockner, S.L. Madrid | Channel Importer, Authorised representative | General hospital and consumables, Dental, Patient monitoring and neurology +2 more | 0 | 0 | 3 | 20.6 | 4/5 |
| 15 | A&P ORTHOIMPORTS,SL GRADO | Channel Importer | Dental | 0 | 0 | 4 | 19.2 | 4/5 |
| 16 | AREAFAR, S.L MOLINS DE REI, BARCELONA | Channel Importer | Dental | 0 | 0 | 2 | 17.3 | 4/5 |
| 17 | Acofarma Distribución S.A. Madrid | Channel Importer | Dental, Ear, nose and throat, Patient monitoring and neurology | 0 | 0 | 0 | 13.1 | 3/5 |
| 18 | TERRATS MEDICAL, S.L. Barbera del Valles. | Holder Registration holder, Manufacturer | Dental, Orthopaedics, spine and trauma | 569 | 3 | 0 | 56.4 | 3/5 |
| 19 | IMPLANT PROTESIS DENTAL 2004, S.L. Premià de Dalt, Barcelona | Holder Registration holder, Manufacturer, Exporter | Dental, Orthopaedics, spine and trauma, Imaging, radiology and radiotherapy | 111 | 3 | 0 | 49.8 | 4/5 |
| 20 | CERAROOT S.L. Les Franqueses del Vallès | Holder Registration holder, Manufacturer, Exporter | Dental, Orthopaedics, spine and trauma, Surgery and endoscopy | 8 | 3 | 0 | 37.0 | 4/5 |
Questions about dental distributors in Spain
How many dental distributors are there in Spain?
The Index counts 26 establishments in Spain with dental in their registry record, of which 17 hold a channel role as importer, distributor, wholesaler or authorised representative. The number comes from EUDAMED, US FDA (openFDA), Health Canada and web and was last refreshed on 22 October 2026.
Who can hold a dental device registration in Spain?
In the EU and EEA the manufacturer, or its EU authorised representative for manufacturers based outside the EU, registers in EUDAMED and holds the CE marking file. Importers and distributors register separately as economic operators and never own the registration, which is why EU channel changes are easier than elsewhere.
How do I find a dental distributor in Spain?
Open the top establishments on this page and check their roles, principals and registration counts. Then search the Index for your device and Spain 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 Spain?
A company that appears in a public regulatory registry with an address in Spain 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 Spain
Dental in other EU and EEA markets
Sources
- EUDAMED economic operator registration, European Commission public API: 23 establishments, last seen 23 October 2026. CC BY 4.0. Data filtered and reformatted by Bastion Hale.
- US FDA Establishment Registration and Device Listing, openFDA bulk download: 20 establishments, last seen 22 October 2026. US government work, public domain.
- Health Canada MDALL active licence listing and MDEL establishment licence listing: 7 establishments, last seen 22 October 2026. Contains information licensed under the Open Government Licence, Canada.
- web (public register): 6 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.