BEUDAMED
    FDA Registration Active 🇺🇸 United States

    HU-FRIEDY MFG CO., LLC

    Reg #: 3009968482 · FEI: 3009968482 · Expires 2026
    View on FDA
    Products
    76
    Proprietary Names
    77
    Establishment Types
    4
    Classifications
    76

    Registration Details

    Registration Name
    HU-FRIEDY MFG CO., LLC
    Registration Number
    3009968482
    FEI Number
    3009968482
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    1666 E Touhy Ave
    City
    Des Plaines
    State
    IL
    ZIP
    60018
    Country
    US

    Regulatory Submissions

    510(k) Number
    K875193

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

    Proprietary Names

    Surgical Blades Osteotome Hu-Friedy Mfg Co.,LLC PULP CANAL FILLING MATERIAL IMS Indicator Strip Hu-Friedy Mfg Co Hu-Friedy Isolation Gown, single-use ROOT CANAL PLUGGER IMS Bagette Mouth Gag HuFriedyGroup PWR Classic Powder PWR Perio Powder Hu-Friedy Mfg Co., LLC Endo Plier Symmetry Piezoelectric Scaling Tips IMS Steri Container Hu-Friedy Mfg Co LLC IMS Bagettes IMS Universal Wrap IMS Autoclave Wrap Periodonitic Marker AMALGAM CARVERS FILES Towel Clamp After Five Prophy Plus After Five Plus Streamline Prophy Style Furcation Plus Swivel Swivel Direct Flow MARGIN FINISHING Enzymax Liquid Ultrasonic Detergent and Presoak Bottle Enzymax Spray Gel Ready-to-Use Instrument Precleaner Enzymax Powder Ultrasonic Detergent and Presoak IMS Daily Clean General Purpose Detergent Enzymax Liquid Concentrated Ultrasonic Detergent and Presoak Enzymax PAX Ultrasonic Detergent and Presoak Powder Cartridge Syringe PWR Air FORCEPS Swerv3 Ultrasonic Scaler Spore Check Spore Test Hu-Friedy Mfg PWR Piezo Tips PWR Piezo PWR Handpiece PWR Pair Subgingival PWR Perio Tips MULIPLE MARGIN FILE Pumice Cup IMS Monitor Tape Knife Rongeurs ORTHODONTIC BAND PUSHER IMS Cassette System Scalpel Handle Hu-Friedy Mfg. Co., LLC Hu-Friedy Mfg,Co.,LLC Crosstex Hu-Friedy Stainless Steel Crowns HEMOSTAT MALLET Rubber Dam Frame ROOT TIP ELEVATORS DENTAL ELEVATORS DENTAL EXPLORER Symmetry IQ Ultrasonic Generator Spore Check Incubator AMALGAM AND FOIL AMALGAM PLUGGERS Hu-Friedy Mfg.Co.,LLC

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Complaint File Establishment per 21 CFR 820.198