BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    GEBR. BRASSELER GMBH & CO. KG

    Reg #: 8010468 · FEI: 3002806577 · Expires 2026
    View on FDA
    Products
    50
    Proprietary Names
    43
    Establishment Types
    5
    Classifications
    50

    Registration Details

    Registration Name
    GEBR. BRASSELER GMBH & CO. KG
    Registration Number
    8010468
    FEI Number
    3002806577
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    ATTN.: Petra Meier, Trophagener Weg 25
    City
    LEMGO North Rhine-Westphalia
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K944714

    Owner / Operator

    Firm Name
    GEBR. BRASSELER GMBH & CO. KG
    Operator Number
    8010468
    Address
    25 TROPHAGENER WEG
    City
    LEMGO
    State
    DE-NOTA
    Postal Code
    D-32657
    Country
    DE
    Correspondent
    Sandra Rabe

    US Agent

    Business Name
    KOMET USA LLC
    Contact Name
    Imke Lindenbeck
    Address
    1057 Red Ventures Drive, Suite 100
    City
    Fort Mill
    State
    SC
    ZIP
    29707
    Country
    US
    Email
    [email protected]
    Phone
    803 3231504

    Products

    Device Name Product Code
    Handpiece, Air-Powered, Dental EFB
    Driver, Prosthesis HWR
    Abutment, Implant, Dental, Endosseous NHA
    Implant, Endosseous, Root-Form DZE
    Handpiece, Direct Drive, Ac-Powered EKX
    Locator, Root Apex LQY
    Plugger, Root Canal, Endodontic EKR
    Scaler, Ultrasonic ELC
    Bur, Dental EJL
    Plate, Fixation, Bone HRS
    Appliance, Fixation, Spinal Intervertebral Body KWQ
    Thoracolumbosacral Pedicle Screw System NKB
    Orthopedic Augmented Reality SBF
    Disk, Abrasive EHJ
    Resin, Root Canal Filling KIF
    Instrument, Diamond, Dental DZP
    File, Pulp Canal, Endodontic EKS
    Driver, Surgical, Pin GFC
    Tap, Bone HWX
    Tray, Surgical, Instrument FSM
    Instrument, Filling, Plastic, Dental EIY
    Guide, Surgical, Instrument FZX
    Bur, Surgical, General & Plastic Surgery GFF
    Screw, Fixation, Bone HWC
    Drill, Bone, Powered DZI
    Orthopedic Stereotaxic Instrument OLO
    Drill, Dental, Intraoral DZA
    Pin, Fixation, Smooth HTY
    Pin, Fixation, Threaded JDW
    Drills, Burrs, Trephines & Accessories (Simple, Powered) HBE
    Accessories, Implant, Dental, Endosseous NDP
    Spreader, Pulp Canal Filling Material, Endodontic EKK
    Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
    Blade, Saw, General & Plastic Surgery, Surgical GFA
    Bit, Drill HTW
    Burr, Corneal, Battery Powered, Rust Ring Removal OHW
    Strip, Polishing Agent EHM
    Orthopedic Manual Surgical Instrument LXH
    Post, Root Canal ELR
    Point, Abrasive EHL
    Reamer, Pulp Canal, Endodontic EKP
    Sacroiliac Joint Fixation OUR
    Syringe, Periodontic, Endodontic, Irrigating EIC
    Point, Paper, Endodontic EKN
    Device, Monitoring, Intracranial Pressure GWM
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Wrench HXC
    Plate, Bone JEY
    Gutta-Percha EKM
    Template HWT

    Proprietary Names

    KOMET SONIC HANDPIECE EndoPilot² KOMET DENTAL STEEL BURS, KOMET DENTAL TUNGSTEN CARBIDE BURS, KOMET DENTAL CERAMIC BURS, SHANK EXTENSION Pedicle Screw System KOMET ABRASIVE DISK KometSeal Abutment Retrieval Kit KOMET DENTAL DIAMOND INSTRUMENTS KOMET CERADRILL KOMET ENDODONTIC ROOT CANAL FILE, K-FILE, HEDSTROEM FILE KOMET Driver, Surgical, Pin Obtura Needle Lock Nuts, Thermal Protectors, Applicator Needles, KOMET TRAY SURGICAL INSTRUMENT KOMET VARIOUS TYPES OF DENTAL HAND INSTRUMENTS Guide Pin KOMET SURGICAL BUR GENERAL & PLASTIC SURGERY KOMET BONE CUTTING INSTRUMENT AND ACCESSORY KOMET INTRAORAL DENTAL DRILL KOMET PIN, FIXATION, SMOOTH KOMET PIN, FIXATION, THREADED KOMET SCREW, FIXATION, BONE Steel Bur / Shaping Drill KOMET ROOT CANAL SPREADER, NERVE BROACHES W&H, Synea, Oscillating Contra Angle KOMET BioSeal Gutta Percha Obturation Device, Fi-P, Fi-G, Fi-E D-PACK HEATING TIPS KOMET BioRepair EnDrive KOMET SURGICAL SAW BLADE GENERAL & PLASTIC SURGERY Cross Pin KOMET STEEL BURR FOR OPHTHALMOLOGY KOMET POLISHING STRIP Orthopaedic Steel Instrument KOMET ROOT CANAL POST KOMET ABRASIVE POINT KOMET ENDODONTIC ROOT CANAL REAMER KOMET OSCILLATING CONTRA-ANGEL Komet BioSeal Flex Tips KOMET PAPER POINTS KOMET ORTHOPEDIC MANUAL SURGICAL INSTRUMENTS KOMET GUTTAPERCHA ROD TEMPLATE

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility Repack or Relabel Medical Device