BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    HAGER & MEISINGER GMBH

    Reg #: 8010516 · FEI: 3004169071 · Expires 2026
    View on FDA
    Products
    22
    Proprietary Names
    137
    Establishment Types
    2
    Classifications
    22

    Registration Details

    Registration Name
    HAGER & MEISINGER GMBH
    Registration Number
    8010516
    FEI Number
    3004169071
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    HANSEMANNSTRASSE 10
    City
    NEUSS North Rhine-Westphalia
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K162073

    Owner / Operator

    Firm Name
    HAGER & MEISINGER GMBH
    Operator Number
    8010516
    Address
    HANSEMANNSTRASSE 10, --
    City
    NEUSS
    State
    DE-NOTA
    Postal Code
    D-41468
    Country
    DE

    US Agent

    Business Name
    Meisinger USA
    Contact Name
    Ethan Miller
    Address
    10150 E Easter Ave
    City
    Centennial
    State
    CO
    ZIP
    80112
    Country
    US
    Email
    [email protected]
    Phone
    303 2685400

    Products

    Device Name Product Code
    Implant, Endosseous, Root-Form DZE
    Point, Abrasive EHL
    Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
    Screw, Fixation, Intraosseous DZL
    Accessories, Implant, Dental, Endosseous NDP
    Forceps, Tooth Extractor, Surgical EMG
    Strip, Polishing Agent EHM
    Drills, Burrs, Trephines & Accessories (Simple, Powered) HBE
    Burr, Orthopedic HTT
    Drill, Dental, Intraoral DZA
    Instruments, Dental Hand DZN
    Abutment, Implant, Dental, Endosseous NHA
    Dental Implant Surgical Tray OFY
    Attachment, Precision, All EGG
    Bur, Dental EJL
    Osteotome HWM
    Bur, Ear, Nose And Throat EQJ
    Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece ERL
    Bone Mill LYS
    Instrument, Diamond, Dental DZP
    Bur, Surgical, General & Plastic Surgery GFF
    File, Pulp Canal, Endodontic EKS

    Proprietary Names

    OKTAGON Bone Level and Tissue Level Implant Variations MEISINGER Abrasives Meisinger Dental Bone Screw Screw System TX (Professional) OKTAGON Emergency Tool OKTAGON Tap OKTAGON Abutment Driver Meisinger Screwdriver OKTAGON Positioning Cylinder OKTAGON Abutment Analog OKTAGON Screwdriver OKTAGON Adapter OKTAGON Holding Key OKTAGON X-Ray Reference Sphere OKTAGON Implant Analog OKTAGON Torque Ratchet OKTAGON Impression Cap myplant two Positioning Key myplant two Seating Instrument OKTAGON Sleeve Holder myplant two Screwdriver myplant two Tap myplant two Handle Laboratory myplant two High Torque Adapter myplant two Torque Indicator myplant two Backturn Instrument myplant two Repositioning Post myplant two Laboratory Analog Ball Anchor myplant two Revision Instrument myplant two Wax-Up Coping myplant two Laboratory Analog One-Piece myplant two Trial Abutment myplant two Transfer Post myplant two Transfer Cap myplant two Seating Instrument Ball Anchor myplant two Open-End Wrench myplant two Ratchet myplant two Implant Analog myplant two Hand Wheel BONE MANAGEMENT MEISINGER Spreader Endo-Extractor Meitrac Extractor MEISINGER BENEX MEISINGER Prophy Strips OKTAGON Twist drills MEI K-Files MEI CT MEI Glide Meisinger Munce Burs MEI Wave Meisinger Pulp Chamber Burs Meisinger Endo Access Burs MEI Sequence MEI Storm OKTAGON Drill Extension MEI Taper MEI Legend MEI Reamers Meisinger Rotary Root Canal Burs Meisinger Twist Drills Benex Twist Drills Meisinger Scissors Meisinger Curette Hand Wheel Meisinger Needle Holder Meisinger Dental Hand Tools OKTAGON Depth Gauge OKTAGON Parallel Pin OKTAGON Direction Indicator Meisinger Forceps Meisinger Scalpell Handle Meisinger Chisel Meisinger Mirror Handle Meisinger Bone Ring Tweezer Meisinger Bone Scraper OKTAGON Implant System OKT Surgical Kit Mini BLT OKT Surgical Kit Mini Drill Stop BLT OKT Micro Kit 3.75 BLT OKT Micro Kit 3.75 TL OKT Micro Kit 3.75 BL Dental Implant OKTAGON myplant two Taper Cap with Retention myplant two Matrix Ball Anchor myplant two O-Ring myplant two Taper Cap Singles Carbide Singles MEISINGER Rotary Tungsten Carbide Instruments OKTAGON Pilot Drill myplant two Tri-Spade Drill myplant two Twist Drill myplant two Initial Bur myplant two Round Drill myplant two Conical Reamer myplant two Drill Extension MEISINGER Rotary Steel Instruments Master-Pin X OSTEOTOME MEISINGER ENT Burs Dental Implant Abutment OKTAGON OKTAGON Prosthetic Parts OKTAGON Plastic Coping OKTAGON Plastic Shoulder Angled Abutments OKTAGON Bone Level myplant two Screw for Ceramics myplant two Healing Cap myplant two Abutment myplant two Dental Implant myplant two Cover Screw myplant two Healing Abutment myplant two Occlusal Screw myplant two Shoulder Abutment myplant two Ball Anchor MP Pin without thread, flat head Dental Implants OKTAGON Bone Level Tapered Design Master Mill Micro Screw System, Micro Screw System Basic OKTAGON Bone Level Implants Meisinger Tacs and Pins Master Pin Control (Basic) MEISINGER Diamond Instruments OKTAGON Twist Drills Periimplantitis Kit Meisinger Tissue Punches Meisinger Trephines OKTAGON Round Bur OKTAGON Countersink OKTAGON Profile Drill Gingiva Cutters Meisinger Stainless Steel Burs Trephine Ejection Kit OKTAGON BL RC Countersink 4.8 mm L=26 mm Master Core Kits MEISINGER SURGICAL BUR MEISINGER

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)