Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1419489

FEI Number

1419489

Entity Name

NORDENT MFG., INC.

City/State/Country

ELK GROVE VILLAGE, IL, US

Establishment Address

610 BONNIE LANE, ELK GROVE VILLAGE, IL 60007, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

NORDENT MFG., INC. (Owner Number: 1419489)

Owner / Operator Contact Address

610 BONNIE LANE, --, Elk Grove Village, IL 60007, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

I LED, I LED II, O-LIGHT, O-LIGHT II Nordent Tape, Measuring, Rulers and Calipers NORDENT ORAL SURGERY ELEVATORS Surgical Mallet ENDO 3 Nordent Spreaders NORDENT PERIODONTAL PROBES NORDENT PERIODONTAL FINISHING AND OR SCALING CURETTES AP-H, AP-H Plus Nordent Lab Carvers NORDENT AMALGAM BURNISHERS Matrix Retainers Brewer Rubber Dam Clamp Forcep ultrasonic scaler Mouth Gag AI PEX Nordent Needle Holder Nordent Rongeur Nordent NORDENT PERIODONTAL FILES NORDENT AMALGAM CONDENSERS Implant Air Nordent Surgical Extraction Forceps Nordent Scalpel Handles AI SURGERY Nordent Surgical Scissors Nordent Suction Tips NORDENT OCHSENBEIN PERIO-CHISEL Calipers Nordent Band Pusher NORDENT EXPLORERS MOTOPEX Nordent Dressing Pliers Nordent Hemostat Nordent Collar Scissors Nordent Band Seater NORDENT BONE FILES Brewer Rubber Dam Clamp Forceps NORDENT AMALGAM CARVERS Nordent Endo Plugger Nordent Amalgam Carrier HATCHETS NORDENT MARGIN TRIMMERS HOES CHISELS D-Laser 16, D-Laser Blue, LX 16, LX16 Plus Nordent Endo Excavator Nordent Gingival Cord Packer Nordent Dental Hand and Surgical Instruments Storage Cassette Nordent Stainless Steel Graft Delivery Syringe with funnel

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EBZ	Activator, Ultraviolet, For Polymerization	Dental	Class 2	872.6070	2025-03-20
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	2024-08-09
EMJ	Elevator, Surgical, Dental	Dental	Class 1	872.4565	1978-02-03
GFJ	Mallet, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2024-02-12
JET	Pick, Massaging	Dental	Class 1	872.6650	2025-03-20
EKK	Spreader, Pulp Canal Filling Material, Endodontic	Dental	Class 1	872.4565	2018-09-05
EIX	Probe, Periodontic	Dental	Class 1	872.4565	1978-02-03
EMS	Curette, Periodontic	Dental	Class 1	872.4565	1978-02-02
EFB	Handpiece, Air-Powered, Dental	Dental	Class 1	872.4200	2025-03-20
EIK	Carver, Wax, Dental	Dental	Class 1	872.4565	2018-09-05
EKJ	Burnisher, Operative	Dental	Class 1	872.4565	1978-02-01
JEP	Retainer, Matrix	Dental	Class 1	872.4565	2024-02-12
EEF	Clamp, Rubber Dam	Dental	Class 1	872.6300	2023-05-22
ELC	Scaler, Ultrasonic	Dental	Class 2	872.4850	2024-03-11
KBN	Gag, Mouth	Ear, Nose, Throat	Class 1	874.4420	2024-02-12
LQY	Locator, Root Apex	Unknown	Class U	N/A	2025-03-20
FHQ	Holder, Needle, Gastroenterologic	Gastroenterology, Urology	Class 1	876.4730	2018-09-05
EMH	Forceps, Rongeur, Surgical	Dental	Class 1	872.4565	2018-09-05
JEX	Plier, Orthodontic	Dental	Class 1	872.4565	2020-02-14
DZP	Instrument, Diamond, Dental	Dental	Class 1	872.4535	2026-04-20
EMR	File, Periodontic	Dental	Class 1	872.4565	1978-02-03
EKG	Condenser, Amalgam And Foil, Operative	Dental	Class 1	872.4565	1978-02-01
EBW	Controller, Foot, Handpiece And Cord	Dental	Class 1	872.4200	2025-03-20
EMG	Forceps, Tooth Extractor, Surgical	Dental	Class 1	872.4565	2018-09-05
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	2018-09-05
ELC	Scaler, Ultrasonic	Dental	Class 2	872.4850	2025-03-20
DZI	Drill, Bone, Powered	Dental	Class 2	872.4120	2025-03-20
EGN	Scissors, Surgical Tissue, Dental	Dental	Class 1	872.4565	2018-09-05
EBR	Unit, Suction Operatory	Dental	Class 1	872.6640	2018-09-05
EMQ	Hoe, Periodontic	Dental	Class 1	872.4565	1978-02-03
KTZ	Caliper	Orthopedic	Class 1	888.4150	2024-02-12
ECS	Pusher, Band, Orthodontic	Dental	Class 1	872.4565	2018-09-05
EKB	Explorer, Operative	Dental	Class 1	872.4565	1978-02-01
EKX	Handpiece, Direct Drive, Ac-Powered	Dental	Class 1	872.4200	2025-03-20
EFL	Forceps, Dressing, Dental	Dental	Class 1	872.4565	2018-09-05
EMD	Hemostat, Surgical	Dental	Class 1	872.4565	2018-09-05
EIR	Scissors, Collar And Crown	Dental	Class 1	872.4565	2018-09-05
ECR	Setter, Band, Orthodontic	Dental	Class 1	872.4565	2018-09-05
EMI	File, Bone, Surgical	Dental	Class 1	872.4565	1978-02-01
EJG	Forceps, Rubber Dam Clamp	Dental	Class 1	872.6300	2024-02-05
EKH	Carver, Dental Amalgam, Operative	Dental	Class 1	872.4565	1978-02-01
EKR	Plugger, Root Canal, Endodontic	Dental	Class 1	872.4565	2018-09-05
EKI	Carrier, Amalgam, Operative	Dental	Class 1	872.4565	2018-09-05
EKD	Instrument, Cutting, Operative	Dental	Class 1	872.4565	1978-02-01
NVK	Laser, Dental, Soft Tissue	General, Plastic Surgery	Class 2	878.4810	2025-03-20
ILY	Lamp, Infrared, Therapeutic Heating	Physical Medicine	Class 2	890.5500	2025-03-20
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2025-03-20
EKT	Curette, Endodontic	Dental	Class 1	872.4565	2018-09-05
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2018-09-05
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2018-09-05
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2024-08-09

Official Correspondent

Anant Shah

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

NORDENT MFG., INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

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K243921	Foshan Coxo Medical Instrument Co., Ltd.	LED Curing Lights (DB686 HALO)	2025-04-11
K033201	Apoza Enterprise Co., Ltd.	LA500 BLUE LIGHT	2003-12-02
K821629	Moyco Industries, Inc.	FIXIDENT	1982-06-14
K212910	Shenzhen Carejoy Technology Co., Ltd.	Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece	2022-11-17
K831136	Almore Intl., Inc.	DOUBLE BOW TOOTH SEPARATOR	1983-06-08

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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-0005-2014	PhotoMedex, Inc.	2	The product is labeled in part "*Surgical Laser Technologies, Inc. Montgomeryville, PASLT Fiber Delivery SystemSterileNon-Pyrogenic**. The product is packaged in a flexible pouch and includes the following laser surgery accessories - SLT-SSRH 8, Catalog/Product Number 0041-3082; SLT-SSRH 11, Catalog/Product Number 0041-3112; SLT-SSRH 4-SMA, Catalog/Product Number 0042-0075; SLT-SSRH 5-SMA, Catalog/Product Number 0042-0076; SLT-SSRH 6-SMA, Catalog/Product Number 0042-0077; SLT-SSRH 7-SMA, Catalog/Product Number 0042-0078; SLT-SSRH 8-SMA, Catalog/Product Number 0042-0079; SLT-SSRH 9-SMA, Catalog/Product Number 0041-4931; and SLT-SSRH 10-SMA, Catalog/Product Number 0042-0081. Indicated for the incision, excision, coagulations, and vaporization of soft tissue.
Z-0025-2018	Medtronic Navigation, Inc.	2	VCLAS (Visualase Cooled Laser Ablation System) Part Number: 9735559 Visualase Cooled Laser Applicator System 3mm Tip; Part Number: 9735560 Visualase Cooled Laser Applicator System 10mm Tip; Part Number: 9735561 Visualase Cooled Laser Applicator System 15mm Tip
Z-0028-2007	Lumenis Inc.	2	Lumenis brand DuoTome SideLite 550 Micron Delivery System; laser systems for ablating soft tissue. Catalog Number: 0641-800-01; Manufactured by Lumenis, Inc., 2400 Condensa Street, Santa Clara, CA
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 1419489. Last updated year: 2026. Please use registration number 1419489 when referencing this establishment in official correspondence.