Nordent Manufacturing, Inc.

Basic Information

• Brand Name: Nordent Manufacturing, Inc.
• Primary DI: 00840018674172
• Version / Model: REOTN120
• Catalog Number: Nordent Instruments-Surgical
• Company Name: NORDENT MANUFACTURING INC
• Labeler DUNS: 053187985
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-02-11
• Public Version: 1
• Public Version Date: 2026-02-19
• Public Version Status: New
• Public Device Record Key: a3fbb97f-8e40-48e5-a46f-12baad533c4c

Device Description

Orthodontic, SE, Ligature Director #N120 (Curved)

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ECP	Instrument, Ligature Tucking, Orthodontic	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
10825	Orthopaedic chisel	A hand-held, single-blade surgical instrument, bevelled on one side, designed to cut and shape bone during orthopaedic surgery. It is hand-held by the operator who uses a surgical mallet or hammer to manually impart a force to the proximal end of the instrument. The distal end (the cutting or shaping edge) is sharp, flat or curved [(concave) - also known as a hollow blade] in design. It is either entirely made of metal (e.g., high-grade stainless steel) or has a metal blade with a handle made of synthetic material (e.g., Tufnol). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840018674172	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Length	6.5	Inch

Storage Conditions

• Type: Handling Environment Humidity
• Temperature Range: 40 – 60 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 0 – 350 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: 65 – 75 Degrees Fahrenheit