Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1416605

FEI Number

1416605

Entity Name

HU-FRIEDY MFG. CO. LLC

City/State/Country

CHICAGO, IL, US

Establishment Address

3232 N Rockwell St, CHICAGO, IL 60618, US

Establishment Type(s)

Manufacture 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

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EMR	File, Periodontic	Dental	Class 1	872.4565	1977-12-12
EMQ	Hoe, Periodontic	Dental	Class 1	872.4565	1998-11-30
EMF	Knife, Surgical	General, Plastic Surgery	Class 1	878.4800	2000-05-19
LYS	Bone Mill	Orthopedic	Class 1	888.4540	2020-03-04
EFL	Forceps, Dressing, Dental	Dental	Class 1	872.4565	1998-03-31
FRC	Indicator, Biological Sterilization Process	General Hospital	Class 2	880.2800	2024-03-15
EIG	Retractor, All Types	Dental	Class 1	872.4565	1977-12-12
EKA	File, Margin Finishing, Operative	Dental	Class 1	872.4565	1977-12-12
ELC	Scaler, Ultrasonic	Dental	Class 2	872.4850	2010-04-01
EIR	Scissors, Collar And Crown	Dental	Class 1	872.4565	1998-11-25
EKD	Instrument, Cutting, Operative	Dental	Class 1	872.4565	1977-12-12
EFK	Forceps, Articulation Paper	Dental	Class 1	872.4565	1998-03-31
EKJ	Burnisher, Operative	Dental	Class 1	872.4565	1977-12-12
EJZ	Knife, Margin Finishing, Operative	Dental	Class 1	872.4565	1977-12-12
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2007-12-13
EMK	Curette, Surgical, Dental	Dental	Class 1	872.4565	1977-12-12
NBY	Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene	General, Plastic Surgery	Class 2	878.5035	2020-10-09
EKC	Excavator, Dental, Operative	Dental	Class 1	872.4565	1977-12-12
GEJ	Carrier, Ligature	General, Plastic Surgery	Class 1	878.4800	1998-11-30
KBN	Gag, Mouth	Ear, Nose, Throat	Class 1	874.4420	1998-11-30
EJY	Pliers, Operative	Dental	Class 1	872.4565	1998-11-30
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	Class 2	880.2800	2022-08-23
ELC	Scaler, Ultrasonic	Dental	Class 2	872.4850	2007-12-13
EJI	Syringe, Cartridge	Dental	Class 2	872.6770	2013-03-13
EIB	Syringe, Irrigating (Dental)	Dental	Class 1	872.4565	2009-07-15
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	Class 2	880.2800	2021-09-15
EMN	Scaler, Periodontic	Dental	Class 1	872.4565	1977-12-12
EMJ	Elevator, Surgical, Dental	Dental	Class 1	872.4565	1977-12-12
EKB	Explorer, Operative	Dental	Class 1	872.4565	1977-12-12
EML	Chisel, Bone, Surgical	Dental	Class 1	872.4565	1977-12-12
GAF	Spatula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1998-11-30
EJB	Handle, Instrument, Dental	Dental	Class 1	872.4565	1998-12-23
EMH	Forceps, Rongeur, Surgical	Dental	Class 1	872.4565	1998-11-30
ECP	Instrument, Ligature Tucking, Orthodontic	Dental	Class 1	872.4565	1998-11-25
EKK	Spreader, Pulp Canal Filling Material, Endodontic	Dental	Class 1	872.4565	1977-12-12
EEF	Clamp, Rubber Dam	Dental	Class 1	872.6300	1998-11-25
EKG	Condenser, Amalgam And Foil, Operative	Dental	Class 1	872.4565	1977-12-12
EIY	Instrument, Filling, Plastic, Dental	Dental	Class 1	872.4565	1977-12-12
EKH	Carver, Dental Amalgam, Operative	Dental	Class 1	872.4565	1977-12-12
EMI	File, Bone, Surgical	Dental	Class 1	872.4565	1977-12-12
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	1998-12-23
EMG	Forceps, Tooth Extractor, Surgical	Dental	Class 1	872.4565	1998-11-30
ELC	Scaler, Ultrasonic	Dental	Class 2	872.4850	2007-12-13
FRC	Indicator, Biological Sterilization Process	General Hospital	Class 2	880.2800	2024-02-01
ECS	Pusher, Band, Orthodontic	Dental	Class 1	872.4565	1977-12-12
EMO	Knife, Periodontic	Dental	Class 1	872.4565	1998-11-30

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
3009968482	HU-FRIEDY MFG CO., LLC	Des Plaines, 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
K151482	Bcr Diagnostics, Inc.	BCR-30-min BI and RBIP-ST30 Readout Accessory	2016-02-26
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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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.
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.

Similar Registrations

Registration Number	Establishment Name	Location
3009968482	HU-FRIEDY MFG CO., LLC	Des Plaines, IL, US
8010159	A. SCHWEICKHARDT GMBH & CO. KG	Seitingen-Oberflacht Baden-Wurttemberg, DE
3003969055	Power Dental USA, Inc.	McHenry, IL, US
9680515	TONTARRA MEDIZINTECHNIK GMBH	WURMLINGEN Baden-Wurttemberg, DE
2431166	Sklar Corporation	West Chester, PA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1416605. Last updated year: 2026. Please use registration number 1416605 when referencing this establishment in official correspondence.