Data / Medical devices / United States / Sweden & Martina Inc
Sweden & Martina Inc: FDA-registered device maker in Naperville, IL, United States, 35 510(k) clearances
Sweden & Martina Inc is registered with the FDA (registration 3011276344) in Naperville, IL, United States. It lists 29 device types. The FDA files 35 510(k) clearances under its listings, the newest dated May 26, 2023. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3011276344
- Address
- 916 Spindletree Avenue, Naperville, IL, United States, 60565
- Owner or operator
- Sweden & Martina INC (10048147)
- Roles
- Complaint file establishment
- First device listed
- July 8, 2016
- Registered through
- 2027
- Brand names listed
- "SURGICAL KIT ""ONEBOX""", "SURGICAL KIT ""ONEBOX2""", 15GR ANGLE PRE-MADE POST, REP., 17GR ANGLED PAD ABUT., H3 MM, 17GR ANGLED PAD ABUT., H5 MM, 25GR ANGLE PRE-MADE POST, REP., 30GR ANGLED PAD ABUT., H3 MM, 30GR ANGLED PAD ABUT., H5 MM and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 26, 2023 | K222640 | Sweden & Martina Surgical Trays | KCT | Substantially Equivalent | Sweden & Martina S.P.A. | accessdata.fda.gov |
| May 11, 2023 | K222549 | OpenTex | NPK | Substantially Equivalent | Purgo Biologics, Inc. | accessdata.fda.gov |
| November 4, 2020 | K182084 | Sweden & Martina Surgical Tray (Model ZSHORTY-INT) | KCT | Substantially Equivalent | Sweden & Martina S.P.A. | accessdata.fda.gov |
| November 26, 2019 | K182892 | TRAUS Dental Handpieces | EGS | Substantially Equivalent | Saeshin Precision Co., Ltd. | accessdata.fda.gov |
| July 16, 2019 | K180992 | Biotex | NBY | Substantially Equivalent | Purgo Biologics, Inc. | accessdata.fda.gov |
| July 8, 2019 | K180365 | PRAMA White Implant Systems | DZE | Substantially Equivalent | Sweden & Martina S.P.A. | accessdata.fda.gov |
| December 20, 2018 | K173041 | 3DIEMME RealGUIDE | LLZ | Substantially Equivalent | 3Diemme , Ltd. | accessdata.fda.gov |
| July 20, 2018 | K173188 | The Graft Natural Bone Substitute | NPM | Substantially Equivalent | Purgo Biologics, Inc. | accessdata.fda.gov |
| February 1, 2018 | K161989 | PREMIUM Implant Systems SHELTA Implant Systems | NHA | Substantially Equivalent | Sweden & Martina S.P.A. | accessdata.fda.gov |
| December 21, 2017 | K172560 | PREMIUM ONE Implant Systems | DZE | Substantially Equivalent | Sweden & Martina S.P.A. | accessdata.fda.gov |
| July 18, 2017 | K170100 | CreoDent Solidex Customized Abutment and Screw | NHA | Substantially Equivalent | Creodent Prosthetics, Ltd. | accessdata.fda.gov |
| July 18, 2017 | K163714 | OSSIX BONE | NPM | Substantially Equivalent | Datum Dental, Ltd. | accessdata.fda.gov |
| February 9, 2017 | K162158 | Porcine Anorganic Bone Mineral in Delivery Applicator | NPM | Substantially Equivalent | Collagen Matrix, Inc. | accessdata.fda.gov |
| August 4, 2016 | K160281 | OSSIX PLUS | NPL | Substantially Equivalent | Datum Dental, Ltd. | accessdata.fda.gov |
| August 4, 2016 | K153549 | OSSIX VOLUMAX | NPL | Substantially Equivalent | Datum Dental, Ltd. | accessdata.fda.gov |
| June 23, 2016 | K152600 | Collagen Dental Wound Dressings | KGN | Substantially Equivalent | Collagen Matrix, Inc. | accessdata.fda.gov |
| November 25, 2015 | K142211 | OT EQUATOR | NHA | Substantially Equivalent | Rhein'83 Srl | accessdata.fda.gov |
| November 2, 2015 | K143584 | PGA RESORBA, PGA RESOQUICK, GLYCOLON | GAM | Substantially Equivalent | Resorba Medical GmbH | accessdata.fda.gov |
| February 2, 2015 | K142242 | PREMIUM, SHELTA Implant Systems | DZE | Substantially Equivalent | Sweden & Martina S.P.A. | accessdata.fda.gov |
| December 31, 2014 | K142124 | AEU-6000 IMPLANT / ENDODONTIC DENTAL SYSTEM | EKX | Substantially Equivalent | Aseptico, Inc. | accessdata.fda.gov |
| November 5, 2014 | K141909 | COLLAGEN DENTAL MEMBRANE - CONFORMABLE PP | NPL | Substantially Equivalent | Collagen Matrix, Inc. | accessdata.fda.gov |
| July 16, 2014 | K140714 | PORCINE ANORGANIC BONE MINERAL | NPM | Substantially Equivalent | Collagen Matrix, Inc. | accessdata.fda.gov |
| February 12, 2014 | K132464 | PTFE SURGICAL SUTURE | NBY | Substantially Equivalent | Omnia Spa | accessdata.fda.gov |
| January 10, 2014 | K130235 | SURFUSE II GEL, SURFUSE II PUTTY, EXFUSE II GEL, EXFUSE II PUTTY | NUN | Substantially Equivalent | Hans Biomed Corp. | accessdata.fda.gov |
| July 11, 2013 | K121310 | MESOTHELIUM DENTAL MEMBRANE | NPL | Substantially Equivalent | Kensey Nash Corporation | accessdata.fda.gov |
| August 11, 2010 | K100156 | COLLAGEN DENTAL MEMBRANE V | NPL | Substantially Equivalent | Collagen Matrix, Inc. | accessdata.fda.gov |
| March 15, 2010 | K093122 | MBCP+ | LYC | Substantially Equivalent | Biomatlante | accessdata.fda.gov |
| July 29, 2008 | K080939 | SURGICAL HANDPIECES, MIKRO SAW HANDPIECES | KMW | Substantially Equivalent | W&H Dentalwerk Buermoos GmbH | accessdata.fda.gov |
| June 2, 2006 | K060732 | MBCP GEL | LYC | Substantially Equivalent | Biomatlante | accessdata.fda.gov |
| February 22, 2006 | K053260 | OSSIX -PLUS | NPL | Substantially Equivalent | Colbar Lifescience , Ltd. | accessdata.fda.gov |
| May 3, 2005 | K051077 | E-TYPE STRAIGHT HANDPIECE, MODEL AHP-101 | EGS | Substantially Equivalent | Aseptico, Inc. | accessdata.fda.gov |
| January 28, 2002 | K014021 | SHARPOINT COATED, FAST ABSORBING POLYGLYCOLIC ACID SYNTHETIC SUTURE, UNDYED | GAM | Substantially Equivalent | Surgical Specialties Corp | accessdata.fda.gov |
| February 12, 1997 | K965162 | LUKENS PGA, (POLYGLYCOLIC ACID) SYNTHETIC ABSORBABLE SURGICAL SUTURE,COATED, BRAIDED-U.S.P. | GAM | Substantially Equivalent | Lukens Medical Corp. | accessdata.fda.gov |
| January 7, 1994 | K930825 | SUTURE NONABSORBABLE-NYLON,SILK,POLYESTER,STAINLES | GAP | Substantially Equivalent | Surgical Specialties, Inc. | accessdata.fda.gov |
| May 31, 1990 | K896554 | GUT SUTURES | GAL | Substantially Equivalent for Some Indications | Look, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Implant, Endosseous, Root-Form
- All makers of Abutment, Implant, Dental, Endosseous
- All makers of Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
- All makers of Bone Grafting Material, Animal Source
- All makers of Bone Grafting Material, Human Source
- All makers of Handpiece, Contra- And Right-Angle Attachment, Dental
Updated May 26, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.