DENFINITY

Basic Information

• Brand Name: DENFINITY
• Primary DI: 07908738730547
• Version / Model: 10.218.067
• Catalog Number: 10.218.067
• 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: 2026-03-13
• Public Version: 1
• Public Version Date: 2026-03-23
• Public Version Status: New
• Public Device Record Key: 733e994f-0592-4bc4-b870-b71c08b3c8b8

Device Description

Finishing & Polishing Composite Diamond Ceramic Spiral 543 Ra KIT Fine 3 /Pk

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: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EHL	Point, Abrasive	Dental	872.6010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46940	Dental polishing brush	A rotational device, typically composed of a metal shaft with bristles containing silicium carbide material, that is used for the quick grinding and polishing of dental composite materials and hard dental tissues to produce a high shine. It is held in a dental handpiece, which rotates the brush at high speeds [e.g., 5000 revolutions per minute (rpm)]. It is suitable for interproximal areas and occlusal surfaces. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07908738730547	GS1