JAZZ POLISHER

Basic Information

• Brand Name: JAZZ POLISHER
• Primary DI: D690890362
• Version / Model: U89036
• Catalog Number: 89036
• Company Name: Ss White Burs, Inc.
• Labeler DUNS: 151760014
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 20
• Record Status: Published
• Publish Date: 2025-02-19
• Public Version: 3
• Public Version Date: 2025-05-22
• Public Version Status: Update
• Public Device Record Key: 8845c5ae-5404-481d-9b37-496a58e598d8

Device Description

JAZZ RA COMPOSITE POLISHER 1 STEP C1S FLAME - 20 PACK

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: Yes
• 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
EHL	POINT, ABRASIVE	Dental	872.6010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63517	Dental abrasive point, single-use	A sterile rotary endpiece designed to be attached to a dental power tool handpiece to perform a specific rotating mechanical function during a dental or orthodontic procedure, typically for polishing and smoothing natural or restorative dental materials (e.g., to finish a crown). Also referred to as a polisher, it is available in various forms [e.g., conical] and sizes and is made of synthetic polymer materials (e.g., silicone, rubber). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	D690890360	HIBCC
Primary	D690890362	HIBCC

Customer Contacts

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