GATES-GLIDDEN DRILLS RA, N°2

Basic Information

• Brand Name: GATES-GLIDDEN DRILLS RA, N°2
• Primary DI: J01020312
• Version / Model: 20312
• Company Name: Produits dentaires S.A.
• Labeler DUNS: 480420090
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-06-22
• Public Version: 1
• Public Version Date: 2022-06-30
• Public Version Status: New
• Public Device Record Key: d0aa151e-d8d9-463a-925a-d5a7192dfda5

Device Description

Rack of 6 - 32 mm length - Diam 0.70 Gates Glidden are mechanized dental instruments used for accessing to the root canal and enlarging the opening of the coronal part of the root canal, before and after using files. Gates-Glidden are also used for pin or post hole preparation.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: 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
EKQ	Preparer, Root Canal Endodontic	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
31876	Endodontic enlarger, reusable	A manual dental instrument designed to be used to access the root canal and to enlarge the opening of the coronal portion of the root canal. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	J01020312	HIBCC

Customer Contacts

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