Sweden & Martina S.P.A.: FDA clearances and approvals
Sweden & Martina S.P.A. has 8 FDA 510(k) clearances (first 2015, latest 2023), across 3 product codes in 2 review panels. Median 510(k) review time: 256 days. Since 2017 its median was 389 days, against 188 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2015 | 1 | 173 |
| 2016 | 1 | 138 |
| 2017 | 2 | 182 |
| 2018 | 1 | 562 |
| 2019 | 1 | 511 |
| 2020 | 1 | 825 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 267 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Sweden & Martina S.P.A.'s cleared 510(k)s took a median 389 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 188 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | 3 | 3 |
| NHA | Abutment, Implant, Dental, Endosseous | 3 | 3 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 2 | 2 |
Review panels
- Dental (6)
- General Hospital (2)
Most recent Sweden & Martina S.P.A. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K222640 | Sweden & Martina Surgical Trays | KCT | 2023-05-26 | 267 |
| K182084 | Sweden & Martina Surgical Tray (Model ZSHORTY-INT) | KCT | 2020-11-04 | 825 |
| K180365 | PRAMA White Implant Systems | DZE | 2019-07-08 | 511 |
| K161989 | PREMIUM Implant Systems SHELTA Implant Systems | NHA | 2018-02-01 | 562 |
| K172560 | PREMIUM ONE Implant Systems | DZE | 2017-12-21 | 118 |
| K162028 | PREMIUM - SHELTA Prosthetic Components | NHA | 2017-03-24 | 245 |
| K162004 | PREMIUM Implant Systems SHELTA Implant Systems | NHA | 2016-12-05 | 138 |
| K142242 | PREMIUM, SHELTA Implant Systems | DZE | 2015-02-02 | 173 |
Recalls
openFDA lists no recalls under a recalling firm named Sweden & Martina S.P.A..
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 Sweden & Martina S.P.A. have?
Sweden & Martina S.P.A. has 8 FDA 510(k) clearances (first 2015, latest 2023), across 3 product codes in 2 review panels.
How long does FDA take to clear Sweden & Martina S.P.A.'s 510(k)s?
The median time from FDA receipt to decision across Sweden & Martina S.P.A.'s cleared 510(k)s is 256 days. Since 2017: 389 days, versus 188 days for all cleared 510(k)s in the same product codes.
What devices does Sweden & Martina S.P.A. make?
Its most frequent FDA product codes are DZE (Implant, Endosseous, Root-Form, 3); NHA (Abutment, Implant, Dental, Endosseous, 3); KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories, 2).
Has Sweden & Martina S.P.A. had device recalls?
openFDA lists no recalls under a recalling firm name matching Sweden & Martina S.P.A. Related entities may recall under other names.
Next steps
- See all 8 Sweden & Martina S.P.A. clearances with predicates and recalls
- Run predicate analysis for product code DZE, Sweden & Martina S.P.A.'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.