DENFINITY

Basic Information

• Brand Name: DENFINITY
• Primary DI: 07908738730448
• Version / Model: 10.350.061
• Catalog Number: 10.350.061
• 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: 6496954f-f435-4647-af6d-db5773137a8c

Device Description

Saw Diamond Finishing & Polishing Strips 2.50mm Fine 10 /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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EHM	Strip, Polishing Agent	Dental	872.6010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35702	Dental abrasive strip, single-use	A manual dental device in the form of a strip coated with abrasive particles on one or both sides intended to be used for modifying the surface of a tooth or restoration during a dental procedure. It is commonly known as a polishing strip. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07908738730448	GS1