PRAXIS

Basic Information

• Brand Name: PRAXIS
• Primary DI: 07897990300783
• Version / Model: 0002000053
• Catalog Number: 0002000053
• Company Name: TDV DENTAL LTDA
• Labeler DUNS: 900580358
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-02-28
• Public Version: 1
• Public Version Date: 2025-03-10
• Public Version Status: New
• Public Device Record Key: a1fb1c0b-eae3-4d76-b964-0ecfde69c74f

Device Description

Praxis Refill 3/8" - 85 Medium Discs (EN)

Device Characteristics

• Single Use: Yes
• 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: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

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
64617	Dental abrasive disk, single-use	A dental instrument consisting of a circular flat or slightly conical sheet, which may carry or contain 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 (e.g., dentures, fillings, crowns). It is designed to be fixed at its centre to a laboratory mandrel or lathe, and/or intended to be used with a dental power tool handpiece (e.g., straight or contra-angle). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07897990300783	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: – 86 Degrees Fahrenheit