Terrats Medical SL: FDA clearances and approvals
Terrats Medical SL has 23 FDA 510(k) clearances (first 2017, latest 2026), across 2 product codes in 1 review panel. Median 510(k) review time: 110 days. Since 2017 its median was 110 days, against 191 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2017 | 1 | 161 |
| 2018 | 1 | 175 |
| 2019 | 1 | 108 |
| 2020 | 0 | — |
| 2021 | 3 | 124 |
| 2022 | 3 | 90 |
| 2023 | 3 | 89 |
| 2024 | 4 | 94 |
| 2025 | 5 | 90 |
| 2026 | 2 | 124 |
Review time against the same product codes
Since 2017, Terrats Medical SL's cleared 510(k)s took a median 110 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 191 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NHA | Abutment, Implant, Dental, Endosseous | 21 | 21 |
| DZE | Implant, Endosseous, Root-Form | 2 | 2 |
Review panels
- Dental (23)
Most recent Terrats Medical SL 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260564 | DESS Dental Smart Solutions | NHA | 2026-06-09 | 110 |
| K253804 | DESS Dental Smart Solutions | NHA | 2026-04-16 | 139 |
| K251547 | DESS Dental Smart Solutions | NHA | 2025-10-31 | 163 |
| K252384 | DESS® Dental Smart Solutions | NHA | 2025-10-23 | 84 |
| K251280 | DESS® Dental Implants | DZE | 2025-07-23 | 90 |
| K250639 | DESS Dental Smart Solutions | NHA | 2025-05-22 | 80 |
| K243212 | DESS Dental Smart Solutions | NHA | 2025-02-14 | 135 |
| K242340 | DESS Dental Smart Solutions | NHA | 2024-11-05 | 90 |
| K240982 | DESS Dental Smart Solutions | NHA | 2024-08-26 | 138 |
| K240208 | DESS Dental Smart Solutions | NHA | 2024-04-24 | 90 |
13 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Terrats Medical SL.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Terrats Medical SL have?
Terrats Medical SL has 23 FDA 510(k) clearances (first 2017, latest 2026), across 2 product codes in 1 review panel.
How long does FDA take to clear Terrats Medical SL's 510(k)s?
The median time from FDA receipt to decision across Terrats Medical SL's cleared 510(k)s is 110 days. Since 2017: 110 days, versus 191 days for all cleared 510(k)s in the same product codes.
What devices does Terrats Medical SL make?
Its most frequent FDA product codes are NHA (Abutment, Implant, Dental, Endosseous, 21); DZE (Implant, Endosseous, Root-Form, 2).
Has Terrats Medical SL had device recalls?
openFDA lists no recalls under a recalling firm name matching Terrats Medical SL. Related entities may recall under other names.
Next steps
- See all 23 Terrats Medical SL clearances with predicates and recalls
- Run predicate analysis for product code NHA, Terrats Medical SL's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.