Talladium España, SL: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Talladium España, SL” (first 2021, latest 2026), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 178 days. Since 2017 the median was 178 days, against 164 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2021 | 1 | 80 |
| 2022 | 0 | — |
| 2023 | 2 | 130 |
| 2024 | 1 | 178 |
| 2025 | 2 | 228 |
| 2026 | 1 | 421 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Talladium España, SL took a median 178 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 164 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NHA | Abutment, Implant, Dental, Endosseous | 6 | 6 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 1 | 1 |
Review panels
- Dental (6)
- General Hospital (1)
Most recent Talladium España, SL 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K243732 | Multi-Unit DAS System | NHA | 2026-01-29 | 421 |
| K243425 | Guided DAS Surgical Kit | KCT | 2025-07-22 | 260 |
| K243530 | Dynamic TiBase | NHA | 2025-05-30 | 197 |
| K241170 | Dynamic TiBase; TRI Screws | NHA | 2024-10-21 | 178 |
| K231559 | Multi-Unit DAS System | NHA | 2023-11-17 | 171 |
| K232151 | Dynamic TiBase | NHA | 2023-10-17 | 90 |
| K212108 | Dynamic TiBase | NHA | 2021-09-24 | 80 |
Recalls
openFDA lists no recalls under a recalling firm named Talladium España, SL.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Talladium, Inc. (7 510(k)s)
- Talladium Espana, SL (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Talladium España, SL?
FDA lists 7 510(k) clearances under the applicant name “Talladium España, SL” (first 2021, latest 2026), across 2 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Talladium España, SL?
The median time from FDA receipt to decision across 510(k)s cleared under the name Talladium España, SL is 178 days. Since 2017: 178 days, versus 164 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Talladium España, SL?
The most frequent FDA product codes under this applicant name are NHA (Abutment, Implant, Dental, Endosseous, 6); KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories, 1).
Next steps
- See all 7 Talladium España, SL clearances with predicates and recalls
- Run predicate analysis for product code NHA, Talladium España, SL's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.