Manufacturer registered with FDA
Talladium Espana, SL
LLEIDA, Spain. Lists 2 dental device types with FDA across 1 registered establishment, and holds 9 510(k) clearances as applicant.
- Device types listed
- 2
- Brands and models
- 3
- 510(k) clearances
- 92010–2026
- Markets registered in
- 7114 registrations outside the US
- Establishments
- 1Spain
510(k) clearances per year, 2007–2026
Registered in 7 markets
Where regulators' registries name Talladium Espana, SL as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Talladium Espana, SL | 9 clearances | 2010–2026 | Below |
| Canada | Health Canada | Registration holder | TALLADIUM ESPANA S.L. | 49 | 2016–2026 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Talladium España, S.L. | 31 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Talladium Espana S.L. | 18 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Talladium Espana SL | 12 | 2017–2022 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | TALLADIUM ESPANA SLTALLADIUM ESPAÑA S.L. | 3 | 2019–2022 | Pure Global AI |
| China | NMPA | Registration holder | 西班牙塔拉迪安有限公司TALLADIUM ESPAÑA, S.L. | 1 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Talladium Espana, SL currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | Dynamic Abutment Solutions | 2010 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Biotech DentalDynamic Abutment Solutions | 2010 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Talladium Espana, SL as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 29 Jan 2026 | K243732 | Multi-Unit DAS System | NHA Endosseous Dental Implant Abutment |
| 30 May 2025 | K243530 | Dynamic TiBase | NHA Endosseous Dental Implant Abutment |
| 21 Oct 2024 | K241170 | Dynamic TiBase; TRI Screws | NHA Endosseous Dental Implant Abutment |
| 17 Nov 2023 | K231559 | Multi-Unit DAS System | NHA Endosseous Dental Implant Abutment |
| 17 Oct 2023 | K232151 | Dynamic TiBase | NHA Endosseous Dental Implant Abutment |
| 15 Sep 2022 | K221966 | Dynamic TiBase | NHA Endosseous Dental Implant Abutment |
| 24 Sep 2021 | K212108 | Dynamic TiBase | NHA Endosseous Dental Implant Abutment |
| 4 May 2018 | K162021 | 3.0 Dynamic TiBase | NHA Endosseous Dental Implant Abutment |
| 22 Jun 2010 | K090081 | TALLADIUM INTERNATIONAL IMPLANTOLOGY ABUTMENTS | NHA Endosseous Dental Implant Abutment |
Some of these clearances are listed with FDA today by another company: CBD Dental Lab, Inc. (2).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| TALLADIUM ESPANA, SLFDA reg. 3008517893 | LLEIDA Lerida, Spain | Contract manufacturer, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10033330). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.