Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004193466

FEI Number

3004193466

Entity Name

HU-FRIEDY MFG.CO. LLC ZWEIGNIEDERLASSUNG DEUTSC

City/State/Country

Emmingen-Liptingen Baden-Wurttemberg, DE

Establishment Address

Bogenstrasse 6 - 8, Emmingen-Liptingen Baden-Wurttemberg 78576, DE

Establishment Type(s)

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

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Hu-Friedy Mfg Co.,LLC IMS Universal Wrap IMS Autoclave Wrap Hu-Friedy Mfg Co.,LLC Hu-Friedy Mfg Co.,LLC Periodonitic Marker Hu-Friedy Mfg Co., LLC Hu-Friedy Mfg Co.,LLC Mouth Gag Hu-Friedy Mfg Co.,LLC Knife Swivel Swivel Direct Flow Hu-Friedy Mfg Co.,LLC Hu-Friedy Mfg Co.,LLC Osteotome Hu-Friedy Mfg Co.,LLC Hu-Friedy Mfg Co.,LLC Hu-Friedy Mfg Co.,LLC Hu-Friedy Mfg Co.,LLC ROOT TIP ELEVATORS Hu-Friedy Mfg Co.,LLC DENTAL ELEVATORS Hu-Friedy Stainless Steel Crowns AMALGAM AND FOIL AMALGAM PLUGGERS Hu-Friedy Mfg Co.,LLC IMS Indicator Strip Hu-Friedy Mfg Co.,LLC Hu-Friedy Mfg Co.,LLC MULIPLE MARGIN FILE Hu-Friedy Mfg Co.,LLC Hu-Friedy Mfg Co.,LLC Symmetry IQ Ultrasonic Generator Hu-Friedy Mfg Co.,LLC Hu-Friedy Mfg Co.,LLC Hu-Friedy Mfg Co.,LLC AMALGAM CARVERS FILES Hu-Friedy Mfg Co.,LLC Hu-Friedy Mfg Co., LLC Scalpel Handle Hu-Friedy Mfg Co.,LLC Pumice Cup Hu-Friedy Mfg Co.,LLC Hu-Friedy Mfg Co.,LLC Hu-Friedy Mfg Co.,LLC Rongeurs Hu-Friedy Mfg Co.,LLC Hu-Friedy Mfg Co.,LLC Hu-Friedy Mfg Co LLC IMS Bagettes Hu-Friedy Mfg Co.,LLC IMS Cassette System Hu-Friedy Mfg Co., LLC IMS Bagette Hu-Friedy Mfg Co.,LLC Hu-Friedy Mfg Co.,LLC Hu-Friedy Mfg Co.,LLC Hu-Friedy Mfg Co.,LLC MARGIN FINISHING Hu-Friedy Mfg Co.,LLC Hu-Friedy Mfg Co.,LLC ROOT CANAL Hu-Friedy Mfg Co.,LLC PLUGGER Hu-Friedy Mfg Co.,LLC Rubber Dam Frame Endo Plier Hu-Friedy Mfg Co.,LLC Hu-Friedy Mfg Co., LLC Hu-Friedy Mfg Co.,LLC Hu-Friedy Mfg Co.,LLC MALLET Hu-Friedy Mfg Co.,LLC Hu-Friedy Mfg Co.,LLC Hu-Friedy Mfg Co.,LLC Swerv3 Ultrasonic Scaler Hu-Friedy Mfg Co.,LLC Hu-Friedy Mfg Co., LLC Hu-Friedy Mfg Co.,LLC FORCEPS Hu-Friedy Mfg Co., LLC DENTAL EXPLORER Hu-Friedy Mfg Co.,LLC PULP CANAL FILLING MATERIAL Hu-Friedy Mfg Co.,LLC Hu-Friedy Mfg Co.,LLC IMS Monitor Tape Hu-Friedy Mfg Co.,LLC Hu-Friedy Mfg Co., LLC HEMOSTAT

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2007-12-13
EMK	Curette, Surgical, Dental	Dental	Class 1	872.4565	1977-12-12
EJG	Forceps, Rubber Dam Clamp	Dental	Class 1	872.6300	1998-11-30
EMP	Marker, Periodontic	Dental	Class 1	872.4565	1998-11-30
EML	Chisel, Bone, Surgical	Dental	Class 1	872.4565	1977-12-12
KBN	Gag, Mouth	Ear, Nose, Throat	Class 1	874.4420	1998-11-30
EMO	Knife, Periodontic	Dental	Class 1	872.4565	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
GFI	Osteotome, Manual	General, Plastic Surgery	Class 1	878.4800	1998-11-30
GEJ	Carrier, Ligature	General, Plastic Surgery	Class 1	878.4800	1998-11-30
EAX	Mirror, Mouth	Dental	Class 1	872.4565	1998-11-25
EMF	Knife, Surgical	General, Plastic Surgery	Class 1	878.4800	2000-05-19
EMJ	Elevator, Surgical, Dental	Dental	Class 1	872.4565	1977-12-12
ELZ	Crown, Preformed	Dental	Class 1	872.3330	2011-02-17
EKG	Condenser, Amalgam And Foil, Operative	Dental	Class 1	872.4565	1977-12-12
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	Class 2	880.2800	2007-12-13
EEF	Clamp, Rubber Dam	Dental	Class 1	872.6300	1998-11-25
EKA	File, Margin Finishing, Operative	Dental	Class 1	872.4565	1977-12-12
ELC	Scaler, Ultrasonic	Dental	Class 2	872.4850	2007-12-13
EKI	Carrier, Amalgam, Operative	Dental	Class 1	872.4565	1998-11-30
EMN	Scaler, Periodontic	Dental	Class 1	872.4565	1977-12-12
EFK	Forceps, Articulation Paper	Dental	Class 1	872.4565	1998-03-31
EKH	Carver, Dental Amalgam, Operative	Dental	Class 1	872.4565	1977-12-12
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	1998-11-30
EHK	Cup, Prophylaxis	Dental	Class 1	872.6290	1998-11-25
EMQ	Hoe, Periodontic	Dental	Class 1	872.4565	1998-11-30
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	1998-12-23
EMR	File, Periodontic	Dental	Class 1	872.4565	1977-12-12
EMH	Forceps, Rongeur, Surgical	Dental	Class 1	872.4565	1998-11-30
EIG	Retractor, All Types	Dental	Class 1	872.4565	1977-12-12
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2013-12-05
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2007-12-13
ECP	Instrument, Ligature Tucking, Orthodontic	Dental	Class 1	872.4565	1998-11-25
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2012-01-09
FHQ	Holder, Needle, Gastroenterologic	Gastroenterology, Urology	Class 1	876.4730	1998-11-30
EIR	Scissors, Collar And Crown	Dental	Class 1	872.4565	1998-11-25
EJZ	Knife, Margin Finishing, Operative	Dental	Class 1	872.4565	1977-12-12
EKD	Instrument, Cutting, Operative	Dental	Class 1	872.4565	1977-12-12
EHZ	Evacuator, Oral Cavity	Dental	Class 1	872.6640	2011-12-12
EKR	Plugger, Root Canal, Endodontic	Dental	Class 1	872.4565	1977-12-12
EJE	Frame, Rubber Dam	Dental	Class 1	872.6300	1998-11-30
EJY	Pliers, Operative	Dental	Class 1	872.4565	1998-11-30
GAF	Spatula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1998-11-30
EJL	Bur, Dental	Dental	Class 1	872.3240	2003-06-17
HXL	Mallet	General, Plastic Surgery	Class 1	878.4800	1998-11-30
EJB	Handle, Instrument, Dental	Dental	Class 1	872.4565	1998-12-23
EIS	Remover, Crown	Dental	Class 1	872.4565	1998-11-25
EIX	Probe, Periodontic	Dental	Class 1	872.4565	1977-12-12
ELC	Scaler, Ultrasonic	Dental	Class 2	872.4850	2010-04-01
EIB	Syringe, Irrigating (Dental)	Dental	Class 1	872.4565	2009-07-15
EGN	Scissors, Surgical Tissue, Dental	Dental	Class 1	872.4565	1998-11-25
EMG	Forceps, Tooth Extractor, Surgical	Dental	Class 1	872.4565	1998-11-30
EKB	Explorer, Operative	Dental	Class 1	872.4565	1977-12-12
EKK	Spreader, Pulp Canal Filling Material, Endodontic	Dental	Class 1	872.4565	1977-12-12
EIY	Instrument, Filling, Plastic, Dental	Dental	Class 1	872.4565	1977-12-12
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	Class 2	880.2800	2007-12-13
EMD	Hemostat, Surgical	Dental	Class 1	872.4565	1998-11-30

Official Correspondent

No official correspondent registered.

US Agent Details

Stephanie Wasielewski Business: Hu-Friedy Mfg Co LLC Email: swasielewski@hu-friedy.com Phone: (847) 2574500

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
3009968482	HU-FRIEDY MFG CO., LLC	Des Plaines, IL, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
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
K851721	Artiberia	1200/1 TO 1240/15 VARIOUS TYPES OF DENTAL SCALERS	1985-07-02
K243425	Talladium España, SL	Guided DAS Surgical Kit	2025-07-22
K213209	K1 Medical, LLC	EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device	2021-12-28

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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-0039-2018	Teleflex Medical	1	Pilling Knife Handles: a) REF 352950 b) REF 352953 c) REF 352951 d) REF 352957 e) REF 352952 : Reusable surgical knife handles, which are intended for use with blades which are inserted into a slot in the handle.
Z-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004193466. Last updated year: 2026. Please use registration number 3004193466 when referencing this establishment in official correspondence.