BEUDAMED
    FDA Registration Active 🇿🇦 South Africa

    SOUTHERN IMPLANTS (PTY) LTD

    Reg #: 3003394627 · FEI: 3003394627 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    59
    Establishment Types
    2
    Classifications
    7

    Registration Details

    Registration Name
    SOUTHERN IMPLANTS (PTY) LTD
    Registration Number
    3003394627
    FEI Number
    3003394627
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    ONE ALBERT ROAD
    City
    IRENE Gauteng
    Country
    ZA

    Regulatory Submissions

    510(k) Number
    K052490

    Owner / Operator

    Firm Name
    SOUTHERN IMPLANTS (PTY) LTD
    Operator Number
    9073913
    Address
    ONE ALBERT ROAD, --
    City
    IRENE, GAUTENG
    State
    ZA-NOTA
    Postal Code
    0062
    Country
    ZA

    US Agent

    Business Name
    SOUTHERN IMPLANTS NORTH AMERICA Inc.
    Contact Name
    David Luiz
    Address
    225 Chimney Corner Lane, Suite 3011
    City
    Jupiter
    State
    FL
    ZIP
    33458
    Country
    US
    Email
    [email protected]
    Phone
    561 4720991

    Products

    Device Name Product Code
    Implant, Endosseous, Root-Form DZE
    Material, External Aesthetic Restoration, No Adhesive NOK
    Abutment, Implant, Dental, Endosseous NHA
    Accessories, Implant, Dental, Endosseous NDP
    Dental Abutment Design Software For Dental Laboratory PNP
    Sterilization Wrap Containers, Trays, Cassettes & Other Accessories KCT
    Prosthesis, Nose, Internal FZE

    Proprietary Names

    Co-Axis Implants Implant, Endosseous, Root-Form - NSI hexed and Non hexed External Prosthetic Cap Piccolo Implants Piccolo Abutments screwdrivers, Dental, Intraoral Placement and removal tools, Dental, Intraoral laboratory pieces used for fabrication of dental prosthetics Drill, Tools and Accessories, Dental, Intraoral ZAGA Zygomatic System Provata Co-Axis Implants Provata Abutments Provata Implants Provata PEEK Abutments Piccolo PEEK Abutments TIB Abutments Implant, Endosseous, Root-Form - 12 Deg Co-Axis Tapered Implants Implant, Endosseous, Root-Form - Parrallel Implants External hex implants External Hex Co-Axis Implants 12 degrees External Hex Co-Axis Implants 24 degrees MSC implants External hex passive abutments External hex cosmetic abutments External hex gold abutments abutments External hex titanium abutments External hex compact conicals abutments External hex cobalt chrome abutments External hex anatomical abutments Inversa Implants Inverta Implant Implant, Endosseous, Root-Form - Zygomatic Implants Implant, Endosseous, Root-Form - Internal Oct Parrallel Implants, Internal Oct Tapered Implant Instrument trays Implant, Endosseous, Root-Form - Int Oct Parrallel Implant, Internal Oct Tapered Implant PEEK Abutments Single Platform SP1 Implant System and accessories TIB Abutment System Implant, Endosseous, Root-Form - Max Implant DC Implants and Accessories Deep Conical Implants and Accessories Implant, Endosseous, Root-Form - Tri-Nex Implant External Hex implant System Osseointegrated Fixtures Abutments Osseointegrated Fixtures Accessories Osseointegrated Fixtures Implants MAX Abutments PROMAX Abutments PROMAX Implants TRIMAX Abutments MSC PROMAX Abutment TRIMAX Implants MAX implants MSC MAX Implants Angulated Screw Channel Solution Abutments & SI-BASE Abutments PROVATA Implant System Zygan Implants Oncology Implants ZAGA Abutments

    Establishment Types

    Manufacture Medical Device Export Device to the United States But Perform No Other Operation on Device