# Talladium España, SL

- Location (FDA's records): Lleida, ES
- FDA decisions: 10 (2010–2026): 10 510(k) clearances
- Names in FDA's records: Talladium España, SL (7); Talladium Espana, SL (3)
- Product codes: NHA (9), KCT (1)
- 510(k) review time since 2016: median 178 days, against 158 for FDA's reviews in the same codes and years (3 of 9 faster)
- Predicates its devices cite: 20 (6 its own); citations of its devices by later devices: 8 (6 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Institut Straumann AG: 2 (https://510kreport.com/company/institut-straumann)
- Zimmer Dental, Inc.: 2 (https://510kreport.com/company/zimmer-dental)
- Z-Systems AG: 1 (https://510kreport.com/company/z-systems)
- Blue Sky Bio, LLC: 1 (https://510kreport.com/company/blue-sky-bio)
- Tri Dental Implants Int. AG: 1 (https://510kreport.com/company/tri-dental-implants-int)
- Implant Innovations, Inc.: 1 (https://510kreport.com/company/implant-innovations)
- Nobelpharma USA, Inc.: 1 (https://510kreport.com/company/nobelpharma-usa)
- Straumann USA: 1 (https://510kreport.com/company/straumann-usa)

## Firms that cite its devices most
- Zentek Medical, LLC: 1 (https://510kreport.com/company/zentek-medical)
- Medentis Medical GmbH: 1 (https://510kreport.com/company/medentis-medical)

## Its most-cited devices
- K212108: Dynamic TiBase (2021), cited by 3
- K232151: Dynamic TiBase (2023), cited by 2
- K221966: Dynamic TiBase (2022), cited by 2
- K231559: Multi-Unit DAS System (2023), cited by 1

## Recent decisions
- K243732: Multi-Unit DAS System (Jan 29, 2026)
- K243425: Guided DAS Surgical Kit (Jul 22, 2025)
- K243530: Dynamic TiBase (May 30, 2025)
- K241170: Dynamic TiBase; TRI Screws (Oct 21, 2024)
- K231559: Multi-Unit DAS System (Nov 17, 2023)
- K232151: Dynamic TiBase (Oct 17, 2023)
- K221966: Dynamic TiBase (Sep 15, 2022)
- K212108: Dynamic TiBase (Sep 24, 2021)

Source page: https://510kreport.com/company/talladium-espana