DENFINITY

Basic Information

• Brand Name: DENFINITY
• Primary DI: 07908738730080
• Version / Model: 10.810.022
• Catalog Number: 10.810.022
• Company Name: 3R - INDUSTRIA E COMERCIO EIRELI
• Labeler DUNS: 907197222
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-03-10
• Public Version: 1
• Public Version Date: 2026-03-18
• Public Version Status: New
• Public Device Record Key: b07053cb-ab7e-4416-95c1-6fd3cad1aed5

Device Description

Finishing & Polishing Discs Single Face Maxflex 48 /Pk + 1 Mandrel

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: Yes

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EHJ	Disk, Abrasive	Dental	872.6010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35807	Dental abrasive disk, reusable	A dental instrument consisting of a circular flat or slightly conical sheet carrying or containing an abrasive, intended to perform a circular and/or oscillatory motion for polishing and finishing a cavity preparation and/or for cutting or polishing dental restorations. It is designed to be fixed at its centre to a mandrel and intended to be used with a dental power tool handpiece (e.g., straight or contra-angle). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07908738730080	GS1