BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    HU-FRIEDY MFG.CO. LLC ZWEIGNIEDERLASSUNG DEUTSC

    Reg #: 3004193466 · FEI: 3004193466 · Expires 2026
    View on FDA
    Products
    64
    Proprietary Names
    53
    Establishment Types
    2
    Classifications
    64

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    Registration Details

    Registration Name
    HU-FRIEDY MFG.CO. LLC ZWEIGNIEDERLASSUNG DEUTSC
    Registration Number
    3004193466
    FEI Number
    3004193466
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Bogenstrasse 6 - 8
    City
    Emmingen-Liptingen Baden-Wurttemberg
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K800123

    Owner / Operator

    Firm Name
    Hu-Friedy Mfg Co., LLC
    Operator Number
    1416605
    Address
    1666 E Touhy Ave, --
    City
    Des Plaines
    State
    IL
    Postal Code
    60018
    Country
    US

    US Agent

    Business Name
    Hu-Friedy Mfg Co LLC
    Contact Name
    Stephanie Wasielewski
    Address
    1666 E Touhy Ave
    City
    Des Plaines
    State
    IL
    ZIP
    60018
    Country
    US
    Email
    [email protected]
    Phone
    847 2574500

    Products

    Device Name Product Code
    Wrap, Sterilization FRG
    Curette, Surgical, Dental EMK
    Forceps, Rubber Dam Clamp EJG
    Marker, Periodontic EMP
    Chisel, Bone, Surgical EML
    Gag, Mouth KBN
    Knife, Periodontic EMO
    Scaler, Ultrasonic ELC
    Gauge, Depth, Instrument, Dental EIL
    Osteotome, Manual GFI
    Carrier, Ligature GEJ
    Mirror, Mouth EAX
    Knife, Surgical EMF
    Elevator, Surgical, Dental EMJ
    Crown, Preformed ELZ
    Condenser, Amalgam And Foil, Operative EKG
    Indicator, Physical/Chemical Sterilization Process JOJ
    Clamp, Rubber Dam EEF
    File, Margin Finishing, Operative EKA
    Carrier, Amalgam, Operative EKI
    Scaler, Periodontic EMN
    Forceps, Articulation Paper EFK
    Carver, Dental Amalgam, Operative EKH
    Handle, Scalpel GDZ
    Cup, Prophylaxis EHK
    Hoe, Periodontic EMQ
    Instrument, Manual, Surgical, General Use MDM
    File, Periodontic EMR
    Forceps, Rongeur, Surgical EMH
    Retractor, All Types EIG
    Sterilization Wrap Containers, Trays, Cassettes & Other Accessories KCT
    Tray, Surgical, Instrument FSM
    Instrument, Ligature Tucking, Orthodontic ECP
    Holder, Needle, Gastroenterologic FHQ
    Scissors, Collar And Crown EIR
    Knife, Margin Finishing, Operative EJZ
    Instrument, Cutting, Operative EKD
    Evacuator, Oral Cavity EHZ
    Plugger, Root Canal, Endodontic EKR
    Frame, Rubber Dam EJE
    Pliers, Operative EJY
    Spatula, Surgical, General & Plastic Surgery GAF
    Bur, Dental EJL
    Mallet HXL
    Handle, Instrument, Dental EJB
    Remover, Crown EIS
    Probe, Periodontic EIX
    Syringe, Irrigating (Dental) EIB
    Scissors, Surgical Tissue, Dental EGN
    Forceps, Tooth Extractor, Surgical EMG
    Explorer, Operative EKB
    Spreader, Pulp Canal Filling Material, Endodontic EKK
    Instrument, Filling, Plastic, Dental EIY
    Hemostat, Surgical EMD
    Forceps, Dressing, Dental EFL
    Burnisher, Operative EKJ
    Clamp HXD
    Bar, Preformed EHO
    Syringe, Cartridge EJI
    Excavator, Dental, Operative EKC
    Plier, Orthodontic JEX
    Pusher, Band, Orthodontic ECS
    File, Bone, Surgical EMI
    Curette, Periodontic EMS

    Proprietary Names

    Hu-Friedy Mfg Co.,LLC IMS Universal Wrap IMS Autoclave Wrap Periodonitic Marker Hu-Friedy Mfg Co., LLC Mouth Gag Knife Swivel Swivel Direct Flow Osteotome ROOT TIP ELEVATORS DENTAL ELEVATORS Hu-Friedy Stainless Steel Crowns AMALGAM AND FOIL AMALGAM PLUGGERS IMS Indicator Strip MULIPLE MARGIN FILE Symmetry IQ Ultrasonic Generator AMALGAM CARVERS FILES Scalpel Handle Pumice Cup Rongeurs Hu-Friedy Mfg Co LLC IMS Bagettes IMS Cassette System IMS Bagette MARGIN FINISHING ROOT CANAL PLUGGER Rubber Dam Frame Endo Plier MALLET Swerv3 Ultrasonic Scaler FORCEPS DENTAL EXPLORER PULP CANAL FILLING MATERIAL IMS Monitor Tape HEMOSTAT Symmetry Piezoelectric Scaling Tips Hu-Friedy Towel Clamp After Five Prophy Plus After Five Plus Streamline Prophy Style Furcation Plus Hu-Friedy Mfg Co Cartridge Syringe IMS Steri Container ORTHODONTIC BAND PUSHER

    Establishment Types

    Repack or Relabel Medical Device Export Device to the United States But Perform No Other Operation on Device