BruxZir

Basic Information

• Brand Name: BruxZir
• Primary DI: D7451014BRX00221
• Version / Model: 1014BRX0022
• Catalog Number: 1014BRX0022
• Company Name: Prismatik Dentalcraft, Inc
• Labeler DUNS: 022761689
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 3
• Record Status: Published
• Publish Date: 2023-04-10
• Public Version: 2
• Public Version Date: 2023-08-22
• Public Version Status: Update
• Public Device Record Key: 5ee434d0-4c47-4a25-8a97-78411b43a333

Device Description

BruxZir™ Brown Polishing Disc, 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: 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
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
Unit of Use	D7451014BRX00220	HIBCC
Primary	D7451014BRX00221	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]