EDENTA

Basic Information

• Brand Name: EDENTA
• Primary DI: E3120935RA121
• Version / Model: 0935RA-12
• Catalog Number: P0935
• Company Name: EDENTA ETABLISSEMENT
• Labeler DUNS: 448002915
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 12
• Record Status: Published
• Publish Date: 2022-02-03
• Public Version: 2
• Public Version Date: 2024-04-26
• Public Version Status: Update
• Public Device Record Key: ce7a14f6-5127-4ac2-9549-0b9359cb04b8

Device Description

Amalgam Reducer RA - black

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
EJQ	WHEEL, POLISHING AGENT	Dental	872.6010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
31833	Dental abrasive point, reusable	A rotary endpiece designed to be attached to a dental power tool handpiece to produce an abrasive rotation typically for polishing and smoothing natural or restorative dental materials (e.g., crown) during a dental procedure. Also referred to as a polisher, it is available in various forms (e.g., conical), sizes, and materials [e.g., silicone, rubber, metal, diamond, silicon carbide, aluminium oxide]. 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	E3120935RA12101	HIBCC
Primary	E3120935RA121	HIBCC