NTI

Basic Information

• Brand Name: NTI
• Primary DI: E310M004B1
• Version / Model: M004B
• Catalog Number: 301L
• Company Name: NTI - Kahla GmbH Rotary Dental Instruments
• Labeler DUNS: 314810326
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-01-01
• Public Version: 1
• Public Version Date: 2022-01-10
• Public Version Status: New
• Public Device Record Key: bb271b86-7af6-4b5f-b925-bc2cf260919c

Device Description

NTI Spiral Top Mandrels

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• 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: Yes
• 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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EJQ	WHEEL, POLISHING AGENT	Dental	872.6010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
31868	Dental laboratory mandrel	A round shaft of substantial dimensions designed to be used in the dental laboratory to hold (locked into place) a rotating device, e.g., a grinding or polishing wheel, abrasive disk, circular saw, or a disk, stone or cup used for grinding or polishing; connectors and rotating endpieces may be included with the device. The mandrel will be placed into a laboratory dental handpiece or lathe that will rotate at high speed. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	E310M004B1	HIBCC