EDENTA

Basic Information

• Brand Name: EDENTA
• Primary DI: E3129107116540351
• Version / Model: 9107.11.654.035
• Company Name: EDENTA ETABLISSEMENT
• Labeler DUNS: 448002915
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 6
• Record Status: Published
• Publish Date: 2022-02-03
• Public Version: 1
• Public Version Date: 2022-02-11
• Public Version Status: New
• Public Device Record Key: d58fa6ae-a048-4f1f-adae-5aa946607b44

Device Description

Nerve broache with handle

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: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DZA	DRILL, DENTAL, INTRAORAL	Dental	872.4130	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35784	Endodontic broach, serrated, reusable	A hand-held, manual, dental, cutting instrument with a slender, tapered, serrated/barbed tip intended to be used for shaping and enlarging holes in root canal tissue, particularly dentine, or for extirpating pulp. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	E312910711654035101	HIBCC
Primary	E3129107116540351	HIBCC