BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PRE-MADE REP. POST ANATOMICAL

    Reg #: 3011276344 · FEI: 3011276344 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    28
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    SWEDEN & MARTINA INC
    Registration Number
    3011276344
    FEI Number
    3011276344
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    916 SPINDLETREE AVENUE
    City
    Naperville
    State
    IL
    ZIP
    60565
    Country
    US

    Regulatory Submissions

    510(k) Number
    K161989

    Owner / Operator

    Firm Name
    Sweden & Martina INC
    Operator Number
    10048147
    Address
    916 SPINDLETREE AVENUE
    City
    Naperville
    State
    IL
    Postal Code
    60565
    Country
    US
    Correspondent
    Alessia Pezzato

    Products

    Device Name Product Code
    Implant, Endosseous, Root-Form DZE
    Abutment, Implant, Dental, Endosseous NHA

    Proprietary Names

    PRE-MADE REP. POST ANATOMICAL PRE-ANGLED REP. MILLABLE POST STRAIGHT PAD ABUTMENT, H1.5 MM STRAIGHT PAD ABUTMENT, H4 MM 30GR ANGLED PAD ABUT., H5 MM CASTABLE REP. POST WITH GOLD PLAIN ABUTMENT H2 MM TRANSGINGIVAL HEALING CAP H5MM CAST. NON REP. POST WITH CRCO SIMPLE TEMP. POST TIT. REP. SIMPLE TEMP. POST PEEK+TIT REP 30GR ANGLED PAD ABUT., H3 MM PLAIN ABUTMENT H3 MM TRANSGINGIVAL HEALING CAP H3MM CASTABLE REP. POST WITH CRCO TRANSGINGIVAL HEALING CAP H7MM 17GR ANGLED PAD ABUT., H3 MM PLAIN ABUTMENT H4 MM MILLABLE POST, REP. 17GR ANGLED PAD ABUT., H5 MM STRAIGHT PAD ABUTMENT, H3 MM MILLABLE REP. POST FOR PRE-MADE REP. POST STRAIGHT 25GR ANGLE PRE-MADE POST, REP. SIMPLE TEMP. POST TIT. NON REP CAST. NON REP. POST WITH GOLD 15GR ANGLE PRE-MADE POST, REP. TRANSGINGIVAL HEALING CAP H2MM

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198