Data / Medical devices / Spain / Talladium Espana, SL

Talladium Espana, SL: FDA-registered device maker in LLEIDA Lerida, Spain, 9 510(k) clearances

Name: Talladium Espana, SL FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Talladium Espana, SL is registered with the FDA (registration 3008517893) in LLEIDA Lerida, Spain. It lists 3 device types. The FDA files 9 510(k) clearances under its listings, the newest dated January 29, 2026. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3008517893
Address: C/ Virginia Woolf 17, LLEIDA Lerida, Spain, 25005
Owner or operator: Talladium Espana, SL (10033330)
Roles: Contract manufacturer, Manufacturer
First device listed: August 4, 2010
Registered through: 2026
Brand names listed: Biotech Dental, Dynamic Abutment Solutions

Devices it lists

Device	Product code	Class	Role	Source
Abutment, Implant, Dental, Endosseous	NHA	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Accessories, Implant, Dental, Endosseous	NDP	1	Manufacturer	accessdata.fda.gov
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	KCT	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
January 29, 2026	K243732	Multi-Unit DAS System	NHA	Substantially Equivalent	Talladium España, SL	accessdata.fda.gov
July 22, 2025	K243425	Guided DAS Surgical Kit	KCT	Substantially Equivalent	Talladium España, SL	accessdata.fda.gov
May 30, 2025	K243530	Dynamic TiBase	NHA	Substantially Equivalent	Talladium España, SL	accessdata.fda.gov
October 21, 2024	K241170	Dynamic TiBase; TRI Screws	NHA	Substantially Equivalent	Talladium España, SL	accessdata.fda.gov
November 17, 2023	K231559	Multi-Unit DAS System	NHA	Substantially Equivalent	Talladium España, SL	accessdata.fda.gov
October 17, 2023	K232151	Dynamic TiBase	NHA	Substantially Equivalent	Talladium España, SL	accessdata.fda.gov
September 15, 2022	K221966	Dynamic TiBase	NHA	Substantially Equivalent	Talladium Espana, SL	accessdata.fda.gov
May 4, 2018	K162021	3.0 Dynamic TiBase	NHA	Substantially Equivalent	Talladium Espana, SL	accessdata.fda.gov
June 22, 2010	K090081	TALLADIUM INTERNATIONAL IMPLANTOLOGY ABUTMENTS	NHA	Substantially Equivalent	Talladium Espana, SL	accessdata.fda.gov

Compare with other makers

Updated January 29, 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.