HU-FRIEDY MFG CO., LLC

FDA Device Registration & Listing · Des Plaines, IL, US · Registration 3009968482

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3009968482
FEI Number
3009968482
Entity Name
HU-FRIEDY MFG CO., LLC
City/State/Country
Des Plaines, IL, US
Establishment Address
1666 E Touhy Ave, Des Plaines, IL 60018, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device,Repack or Relabel Medical Device
Owner / Operator
Hu-Friedy Mfg Co., LLC (Owner Number: 1416605)
Owner / Operator Contact Address
1666 E Touhy Ave, --, Des Plaines, IL 60018, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Surgical Blades Osteotome Hu-Friedy Mfg Co.,LLC Hu-Friedy Mfg Co.,LLC Hu-Friedy Mfg Co.,LLC PULP CANAL FILLING MATERIAL Hu-Friedy Mfg Co.,LLC IMS Indicator Strip Hu-Friedy Mfg Co.,LLC Hu-Friedy Mfg Co Hu-Friedy Hu-Friedy Mfg Co.,LLC Hu-Friedy Mfg Co.,LLC Hu-Friedy Mfg Co.,LLC Hu-Friedy Mfg Co.,LLC Isolation Gown, single-use Hu-Friedy Mfg Co.,LLC ROOT CANAL Hu-Friedy Mfg Co.,LLC PLUGGER IMS Bagette Hu-Friedy Mfg Co.,LLC Hu-Friedy Mfg Co.,LLC Mouth Gag HuFriedyGroup PWR Classic Powder PWR Perio Powder Hu-Friedy Mfg Co., LLC Endo Plier Hu-Friedy Mfg Co.,LLC Symmetry Piezoelectric Scaling Tips Hu-Friedy Mfg Co.,LLC IMS Steri Container Hu-Friedy Mfg Co.,LLC Hu-Friedy Mfg Co.,LLC Hu-Friedy Mfg Co LLC IMS Bagettes Hu-Friedy Mfg Co.,LLC IMS Universal Wrap IMS Autoclave Wrap Hu-Friedy Mfg Co., LLC Periodonitic Marker Hu-Friedy Mfg Co., LLC AMALGAM CARVERS FILES Hu-Friedy Mfg Co.,LLC Hu-Friedy Mfg Co.,LLC Hu-Friedy Mfg Co.,LLC Hu-Friedy Mfg Co.,LLC Towel Clamp Hu-Friedy Mfg Co.,LLC After Five Prophy Plus After Five Plus Streamline Prophy Style Furcation Plus Hu-Friedy Mfg Co.,LLC Swivel Swivel Direct Flow Hu-Friedy Mfg Co.,LLC Hu-Friedy Hu-Friedy Mfg Co.,LLC 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 Hu-Friedy Mfg Co.,LLC Hu-Friedy Mfg Co.,LLC Hu-Friedy Mfg Co.,LLC Hu-Friedy Mfg Co., LLC Cartridge Syringe Hu-Friedy Mfg Co.,LLC Hu-Friedy Mfg Co.,LLC PWR Air FORCEPS Hu-Friedy Mfg Co., LLC Swerv3 Ultrasonic Scaler Hu-Friedy Mfg Co.,LLC Hu-Friedy Mfg Co.,LLC Spore Check Spore Test Hu-Friedy Mfg Co.,LLC Hu-Friedy Mfg Co., LLC Hu-Friedy Mfg HuFriedyGroup PWR Piezo Tips PWR Piezo PWR Handpiece PWR Handpiece PWR Pair HuFriedyGroup Subgingival PWR Perio Tips MULIPLE MARGIN FILE Hu-Friedy Mfg Co.,LLC Hu-Friedy Mfg Co.,LLC Hu-Friedy Mfg Co.,LLC Hu-Friedy Mfg Co.,LLC Hu-Friedy Mfg Co.,LLC Pumice Cup IMS Monitor Tape Hu-Friedy Mfg Co.,LLC Hu-Friedy Mfg Co.,LLC Knife Rongeurs Hu-Friedy Mfg Co.,LLC ORTHODONTIC BAND PUSHER Hu-Friedy Mfg Co.,LLC Hu-Friedy Mfg Co.,LLC Hu-Friedy Mfg Co.,LLC IMS Cassette System Hu-Friedy Mfg Co.,LLC Hu-Friedy Mfg Co., LLC Scalpel Handle Hu-Friedy Mfg. Co., LLC Hu-Friedy Mfg,Co.,LLC Crosstex Hu-Friedy Stainless Steel Crowns Hu-Friedy Mfg Co.,LLC Hu-Friedy Mfg Co., LLC HEMOSTAT Hu-Friedy Mfg Co.,LLC Hu-Friedy Mfg Co.,LLC MALLET Hu-Friedy Mfg Co.,LLC Hu-Friedy Hu-Friedy Mfg Co.,LLC Rubber Dam Frame Hu-Friedy Hu-Friedy Mfg Co.,LLC Hu-Friedy Hu-Friedy Mfg Co.,LLC

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GES Blade, Scalpel General, Plastic Surgery Class 1 878.4800 1998-11-30
GFI Osteotome, Manual General, Plastic Surgery Class 1 878.4800 1998-11-30
EMR File, Periodontic Dental Class 1 872.4565 1977-12-12
EMK Curette, Surgical, Dental Dental Class 1 872.4565 1977-12-12
EKK Spreader, Pulp Canal Filling Material, Endodontic Dental Class 1 872.4565 1977-12-12
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2007-12-13
EHO Bar, Preformed Dental Class 1 872.3165 2014-08-26
GAM Suture, Absorbable, Synthetic, Polyglycolic Acid General, Plastic Surgery Class 2 878.4493 2007-12-13
EAX Mirror, Mouth Dental Class 1 872.4565 1998-11-25
FHQ Holder, Needle, Gastroenterologic Gastroenterology, Urology Class 1 876.4730 1998-11-30
EIY Instrument, Filling, Plastic, Dental Dental Class 1 872.4565 1977-12-12
EJG Forceps, Rubber Dam Clamp Dental Class 1 872.6300 1998-11-30
OEA Non-Surgical Gown General, Plastic Surgery Class 1 878.4040 2022-01-31
EIS Remover, Crown Dental Class 1 872.4565 1998-11-25
EKR Plugger, Root Canal, Endodontic Dental Class 1 872.4565 1977-12-12
FRG Wrap, Sterilization General Hospital Class 2 880.6850 2012-01-09
KBN Gag, Mouth Ear, Nose, Throat Class 1 874.4420 1998-11-30
EJR Agent, Polishing, Abrasive, Oral Cavity Dental Class 1 872.6030 2024-07-01
ECP Instrument, Ligature Tucking, Orthodontic Dental Class 1 872.4565 1998-11-25
EJY Pliers, Operative Dental Class 1 872.4565 1998-11-30
ELC Scaler, Ultrasonic Dental Class 2 872.4850 2007-12-13
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2014-03-03
EFK Forceps, Articulation Paper Dental Class 1 872.4565 1998-03-31
GEJ Carrier, Ligature General, Plastic Surgery Class 1 878.4800 1998-11-30
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2013-12-05
FRG Wrap, Sterilization General Hospital Class 2 880.6850 2007-12-13
GAF Spatula, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 1998-11-30
EMP Marker, Periodontic Dental Class 1 872.4565 1998-11-30
EIB Syringe, Irrigating (Dental) Dental Class 1 872.4565 2009-07-15
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2020-05-11
EKH Carver, Dental Amalgam, Operative Dental Class 1 872.4565 1977-12-12
EKC Excavator, Dental, Operative Dental Class 1 872.4565 1977-12-12
EIG Retractor, All Types Dental Class 1 872.4565 1977-12-12
HXD Clamp General, Plastic Surgery Class 1 878.4800 1998-11-30
ELC Scaler, Ultrasonic Dental Class 2 872.4850 2007-12-13
EIL Gauge, Depth, Instrument, Dental Dental Class 1 872.4565 1998-03-31
ELC Scaler, Ultrasonic Dental Class 2 872.4850 2007-12-13
GAW Suture, Nonabsorbable, Synthetic, Polypropylene General, Plastic Surgery Class 2 878.5010 2008-01-29
EJZ Knife, Margin Finishing, Operative Dental Class 1 872.4565 1977-12-12
FLG Cleaner, Ultrasonic, Medical Instrument General Hospital Class 1 880.6150 1998-11-30
EMQ Hoe, Periodontic Dental Class 1 872.4565 1998-11-30
EMS Curette, Periodontic Dental Class 1 872.4565 1977-12-12
EMI File, Bone, Surgical Dental Class 1 872.4565 1977-12-12
EFL Forceps, Dressing, Dental Dental Class 1 872.4565 1998-03-31
EJI Syringe, Cartridge Dental Class 2 872.6770 2013-03-13
EIX Probe, Periodontic Dental Class 1 872.4565 1977-12-12
KOJ Airbrush Dental Class 2 872.6080 2026-01-06
ELC Scaler, Ultrasonic Dental Class 2 872.4850 2026-01-06
EMG Forceps, Tooth Extractor, Surgical Dental Class 1 872.4565 1998-11-30
ELC Scaler, Ultrasonic Dental Class 2 872.4850 2010-04-01
EHZ Evacuator, Oral Cavity Dental Class 1 872.6640 2011-12-12
FRC Indicator, Biological Sterilization Process General Hospital Class 2 880.2800 2006-09-11
EML Chisel, Bone, Surgical Dental Class 1 872.4565 1977-12-12
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2014-06-26
ELC Scaler, Ultrasonic Dental Class 2 872.4850 2024-07-01
ELC Scaler, Ultrasonic Dental Class 2 872.4850 2024-07-01
KOJ Airbrush Dental Class 2 872.6080 2024-07-01
EKA File, Margin Finishing, Operative Dental Class 1 872.4565 1977-12-12
EKI Carrier, Amalgam, Operative Dental Class 1 872.4565 1998-11-30
JEX Plier, Orthodontic Dental Class 1 872.4565 1998-11-30
EJB Handle, Instrument, Dental Dental Class 1 872.4565 1998-12-23
EHK Cup, Prophylaxis Dental Class 1 872.6290 1998-11-25
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2007-12-13
EMO Knife, Periodontic Dental Class 1 872.4565 1998-11-30
EMH Forceps, Rongeur, Surgical Dental Class 1 872.4565 1998-11-30
ECS Pusher, Band, Orthodontic Dental Class 1 872.4565 1977-12-12
EJL Bur, Dental Dental Class 1 872.3240 2003-06-17
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2007-12-13
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 1998-12-23
GDZ Handle, Scalpel General, Plastic Surgery Class 1 878.4800 1998-11-30
DZC Wire, Orthodontic Dental Class 1 872.5410 2015-10-16
GAM Suture, Absorbable, Synthetic, Polyglycolic Acid General, Plastic Surgery Class 2 878.4493 2007-12-13
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2021-11-18
ELZ Crown, Preformed Dental Class 1 872.3330 2011-02-17
EIR Scissors, Collar And Crown Dental Class 1 872.4565 1998-11-25
EMD Hemostat, Surgical Dental Class 1 872.4565 1998-11-30
EGN Scissors, Surgical Tissue, Dental Dental Class 1 872.4565 1998-11-25
HXL Mallet General, Plastic Surgery Class 1 878.4800 1998-11-30
EMF Knife, Surgical General, Plastic Surgery Class 1 878.4800 2000-05-19
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2021-09-15
EJE Frame, Rubber Dam Dental Class 1 872.6300 1998-11-30
GAP Suture, Nonabsorbable, Silk General, Plastic Surgery Class 2 878.5030 2007-12-13
EEF Clamp, Rubber Dam Dental Class 1 872.6300 1998-11-25
EKJ Burnisher, Operative Dental Class 1 872.4565 1977-12-12
EKD Instrument, Cutting, Operative Dental Class 1 872.4565 1977-12-12

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Hu-Friedy Mfg Co., LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3005049358 HU-FRIEDY MFG. CO. LLC PUDONG, SHANGHAI, CN
1416605 HU-FRIEDY MFG. CO. LLC CHICAGO, IL, US
3004193466 HU-FRIEDY MFG.CO. LLC ZWEIGNIEDERLASSUNG DEUTSC Emmingen-Liptingen Baden-Wurttemberg, DE

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K123940 Demetech Corp. DEMEQUICKTM (RAPID ABSORBABLE) SYNTHETIC SURGICAL SUTURE 2014-05-30
K050845 ETHICON, Inc. MONOCRYL PLUS ANTIBACTERIAL SUTURE 2005-06-29
K121698 Dentsply International, Inc. NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMIN 2012-08-06
K832443 California Technics, Inc. ULTRASONIC DENTAL PROPHYLAXIS UNIT 1983-09-12
K994299 Bonart Co., Ltd. ART-P3, MODEL P3-1-ART-A1 2000-03-06

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0012-2008 Becton Dickinson & Company 1
Shelf Pack: Bard-Parker Rib-Back Carbon Steel no.11, surgical blade. Unit Package: Contents of unopened or undamaged package guaranteed sterile; After use place product in a puncture resistant container and dispose properly. Becton Dickinson Becton Dickinson Acute Care Franklin Lakes, NJ 07417
Z-0013-2008 Becton Dickinson & Company 1
Shelf Pack: Bard-Parker Rib-Back Stainless Steel no.11, surgical blade. Unit Package: Contents of unopened or undamaged package guaranteed sterile; After use place product in a puncture resistant container and dispose properly. Becton Dickinson Becton Dickinson Acute Care Franklin Lakes, NJ 07417
Z-0027-2007 N/A 2
3M Comply 1248 Gas Plasma Chemical Indicator Strips for use in STERRAD 100, STERRAD 100S and STERRAD 50 Sterilization Systems. Indicator for hydrogen peroxide sterilant.
Z-0010-2021 Riverpoint Medical, LLC 2
Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 6/0 Undyed 18" P-10 Cutting, Product Number: SV9913, UDI: 20884521153278 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.
Z-0011-2021 Riverpoint Medical, LLC 2
Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" P-14 Cutting, Product Number: SV935, UDI: 20884521151755 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009968482. Last updated year: 2026. Please use registration number 3009968482 when referencing this establishment in official correspondence.
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