BEUDAMED
    FDA Registration Active 🇺🇸 United States

    HU-FRIEDY MFG. CO. LLC

    Reg #: 1416605 · FEI: 1416605 · Expires 2026
    View on FDA
    Products
    57
    Proprietary Names
    42
    Establishment Types
    5
    Classifications
    57

    Registration Details

    Registration Name
    HU-FRIEDY MFG. CO. LLC
    Registration Number
    1416605
    FEI Number
    1416605
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    3232 N Rockwell St
    City
    CHICAGO
    State
    IL
    ZIP
    60618
    Country
    US

    Regulatory Submissions

    510(k) Number
    K181686

    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

    Products

    Device Name Product Code
    File, Periodontic EMR
    Hoe, Periodontic EMQ
    Knife, Surgical EMF
    Bone Mill LYS
    Forceps, Dressing, Dental EFL
    Indicator, Biological Sterilization Process FRC
    Retractor, All Types EIG
    File, Margin Finishing, Operative EKA
    Scaler, Ultrasonic ELC
    Scissors, Collar And Crown EIR
    Instrument, Cutting, Operative EKD
    Forceps, Articulation Paper EFK
    Burnisher, Operative EKJ
    Knife, Margin Finishing, Operative EJZ
    Tray, Surgical, Instrument FSM
    Curette, Surgical, Dental EMK
    Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene NBY
    Excavator, Dental, Operative EKC
    Carrier, Ligature GEJ
    Gag, Mouth KBN
    Pliers, Operative EJY
    Indicator, Physical/Chemical Sterilization Process JOJ
    Syringe, Cartridge EJI
    Syringe, Irrigating (Dental) EIB
    Scaler, Periodontic EMN
    Elevator, Surgical, Dental EMJ
    Explorer, Operative EKB
    Chisel, Bone, Surgical EML
    Spatula, Surgical, General & Plastic Surgery GAF
    Handle, Instrument, Dental EJB
    Forceps, Rongeur, Surgical EMH
    Instrument, Ligature Tucking, Orthodontic ECP
    Spreader, Pulp Canal Filling Material, Endodontic EKK
    Clamp, Rubber Dam EEF
    Condenser, Amalgam And Foil, Operative EKG
    Instrument, Filling, Plastic, Dental EIY
    Carver, Dental Amalgam, Operative EKH
    File, Bone, Surgical EMI
    Instrument, Manual, Surgical, General Use MDM
    Forceps, Tooth Extractor, Surgical EMG
    Pusher, Band, Orthodontic ECS
    Knife, Periodontic EMO
    Plugger, Root Canal, Endodontic EKR
    Mallet HXL
    Handle, Scalpel GDZ
    Scissors, Surgical Tissue, Dental EGN
    Plier, Orthodontic JEX
    Curette, Periodontic EMS
    Osteotome, Manual GFI
    Remover, Crown EIS
    Probe, Periodontic EIX
    Gauge, Depth, Instrument, Dental EIL
    Marker, Periodontic EMP
    Holder, Needle, Gastroenterologic FHQ
    Forceps, Rubber Dam Clamp EJG
    Airbrush KOJ
    Mirror, Mouth EAX

    Proprietary Names

    Hu-Friedy Mfg Co.,LLC Hu-Friedy Mfg Co., LLC ConFirm Rapid 20 Biological Indicator MULIPLE MARGIN FILE Swerv3 Ultrasonic Scaler Hu-Friedy MARGIN FINISHING IMS Cassette System Mouth Gag Endo Plier Hu-Friedy Steam Sterilization Integrator Symmetry Piezoelectric Scaling Tips Cartridge Syringe ROOT TIP ELEVATORS DENTAL ELEVATORS DENTAL EXPLORER Rongeurs PULP CANAL FILLING MATERIAL AMALGAM AND FOIL AMALGAM PLUGGERS AMALGAM CARVERS FILES FORCEPS After Five Prophy Plus After Five Plus Streamline Prophy Style Furcation Plus ConFirm Rapid 20 Incubator ORTHODONTIC BAND PUSHER Knife ROOT CANAL PLUGGER MALLET Scalpel Handle Osteotome Swivel Swivel Direct Flow Periodonitic Marker PWR Air

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility Repack or Relabel Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Complaint File Establishment per 21 CFR 820.198