KENDA

Basic Information

• Brand Name: KENDA
• Primary DI: 07630243641963
• Version / Model: 0558.100
• Catalog Number: 0558.100
• Company Name: Dent4You AG
• Labeler DUNS: 480152811
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2025-09-17
• Public Version: 1
• Public Version Date: 2025-09-25
• Public Version Status: New
• Public Device Record Key: 0f71aa85-eac5-4423-8ec2-370becf4d473

Device Description

KENDA Complete High Shine Polishers for Composite/Compomer/Gold/Amalgam, Point, RA, 100pcs

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
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	07630243637379	GS1
Primary	07630243641963	GS1