Sweden & Martina Inc
Due Carrare Padova, IT
SWEDEN & MARTINA INC appears in FDA device records in Due Carrare Padova, IT. FDA records list 8 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 8 510(k) clearances for Sweden & Martina Inc between 2015 and 2023. The busiest year on record is 2017, with 2. The most recent is 2023, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2015 | 1 |
| 2016 | 1 |
| 2017 | 2 |
| 2018 | 1 |
| 2019 | 1 |
| 2020 | 1 |
| 2023 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K222640 | Sweden & Martina Surgical Trays | KCT | Substantially Equivalent | |
| K182084 | Sweden & Martina Surgical Tray (Model ZSHORTY-INT) | KCT | Substantially Equivalent | |
| K180365 | PRAMA White Implant Systems | DZE | Substantially Equivalent | |
| K161989 | PREMIUM Implant Systems SHELTA Implant Systems | NHA | Substantially Equivalent | |
| K172560 | PREMIUM ONE Implant Systems | DZE | Substantially Equivalent | |
| K162028 | PREMIUM - SHELTA Prosthetic Components | NHA | Substantially Equivalent | |
| K162004 | PREMIUM Implant Systems SHELTA Implant Systems | NHA | Substantially Equivalent | |
| K142242 | PREMIUM, SHELTA Implant Systems | DZE | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3011276344 | 3011276344 | SWEDEN & MARTINA INC | 916 SPINDLETREE AVENUE, Naperville, IL 60565 US | 2026 | and 19 more, listed in full below |
| 3001082453 | 3001082453 | SWEDEN & MARTINA S.P.A. | Via Veneto, 10, Due Carrare Padova 35020 IT | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- NHAAbutment, Implant, Dental, Endosseous
- NDPAccessories, Implant, Dental, Endosseous
- EJXAnchor, Preformed
- NPLBarrier, Animal Source, Intraoral
- NPKBarrier, Synthetic, Intraoral
- NPMBone Grafting Material, Animal Source
- NUNBone Grafting Material, Human Source
- LYCBone Grafting Material, Synthetic
- KDGChisel (Osteotome)
- DZADrill, Dental, Intraoral
- EKMGutta-Percha
- EGSHandpiece, Contra- And Right-Angle Attachment, Dental
- EKXHandpiece, Direct Drive, Ac-Powered
- KMWHandpiece, Rotary Bone Cutting
- DZEImplant, Endosseous, Root-Form
- GEYMotor, Surgical Instrument, Ac-Powered
- EISRemover, Crown
- NSMRestoration, Resin
- NSNRestoration, Resin, Crown And Bridge
- KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories
- GALSuture, Absorbable, Natural
- GAMSuture, Absorbable, Synthetic, Polyglycolic Acid
- GAPSuture, Nonabsorbable, Silk
- GAQSuture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
- GATSuture, Nonabsorbable, Synthetic, Polyethylene
- GAWSuture, Nonabsorbable, Synthetic, Polypropylene
- NBYSuture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
- LLZSystem, Image Processing, Radiological
- KGNWound Dressing With Animal-Derived Material(S)
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain