# Sweden & Martina S.P.A.

- Location (FDA's records): Due Carrare, IT
- FDA decisions: 8 (2015–2023): 8 510(k) clearances
- Product codes: NHA (3), DZE (3), KCT (2)
- 510(k) review time since 2016: median 267 days, against 200 for FDA's reviews in the same codes and years (2 of 7 faster)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 1 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Creodent Prosthetics, Ltd.: 1 (https://510kreport.com/company/creodent-prosthetics)

## Its most-cited devices
- K142242: PREMIUM, SHELTA Implant Systems (2015), cited by 1

## Recent decisions
- K222640: Sweden & Martina Surgical Trays (May 26, 2023)
- K182084: Sweden & Martina Surgical Tray (Model ZSHORTY-INT) (Nov 4, 2020)
- K180365: PRAMA White Implant Systems (Jul 8, 2019)
- K161989: PREMIUM Implant Systems SHELTA Implant Systems (Feb 1, 2018)
- K172560: PREMIUM ONE Implant Systems (Dec 21, 2017)
- K162028: PREMIUM - SHELTA Prosthetic Components (Mar 24, 2017)
- K162004: PREMIUM Implant Systems SHELTA Implant Systems (Dec 5, 2016)
- K142242: PREMIUM, SHELTA Implant Systems (Feb 2, 2015)

Source page: https://510kreport.com/company/sweden-martina