BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    OT MEDICAL GMBH

    Reg #: 3008496301 · FEI: 3008496301 · Expires 2026
    View on FDA
    Products
    8
    Proprietary Names
    28
    Establishment Types
    1
    Classifications
    8

    Registration Details

    Registration Name
    OT MEDICAL GMBH
    Registration Number
    3008496301
    FEI Number
    3008496301
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Am Tabakquartier 62
    City
    Bremen
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K113113

    Owner / Operator

    Firm Name
    OT medical GmbH
    Operator Number
    10033109
    Address
    Am Tabakquartier 62
    City
    Bremen
    State
    DE-HB
    Postal Code
    28197
    Country
    DE

    US Agent

    Business Name
    Emergo Global Representation LLC
    Contact Name
    Yong Sun
    Address
    2500 Bee Cave Rd., Bldg. 1, Ste. 300
    City
    Austin
    State
    TX
    ZIP
    78746
    Country
    US
    Email
    [email protected]
    Phone
    512 3279997

    Products

    Device Name Product Code
    Accessories, Implant, Dental, Endosseous NDP
    Abutment, Implant, Dental, Endosseous NHA
    Implant, Endosseous, Root-Form DZE
    Punch, Biopsy, Surgical EME
    Chisel, Osteotome, Surgical EMM
    Gauge, Depth, Instrument, Dental EIL
    Handle, Instrument, Dental EJB
    Bur, Dental EJL

    Proprietary Names

    Scan Body OT-F1, OT-F2, OT-F3, Bicortic TecLine OT-F² Implants CreativeLine ProfiLine NaturalLine OT-F³ Implants 4plus6Line Abutment Center Punch OT-F³ Trial Fit Gauge OT-F³ Osteotome Tip Preform NaturalLine Abutment Depth Gauge 2 OT-F³ Tip wrench OT-F³ Osteotome Handle, bended OT-F³ Osteotome Handle, straight Final drill Pilot drill Bone Tap Cortical Drill Pilot drill 1 Bone Trephine Implant Driver Prosthetic Driver Pilot drill 2 Interspace drill

    Establishment Types

    Manufacture Medical Device