EDENTA

Basic Information

• Brand Name: EDENTA
• Primary DI: E312178S252040251
• Version / Model: 178S.25.204.025
• Company Name: EDENTA ETABLISSEMENT
• Labeler DUNS: 448002915
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 4
• 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: 450aff98-210b-45fd-999a-79060af53d7a

Device Description

Root fillers " L"

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
41539	Endodontic filling material carrier	A mains electricity (AC-powered) endodontic instrument designed specifically to convey filling materials or medications into a root canal. The working part of the instrument is typically a helicoidal or conical spring. This is a reusable device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	E312178S25204025101	HIBCC
Primary	E312178S252040251	HIBCC