EXPRESS LINE DIAMOND

Basic Information

• Brand Name: EXPRESS LINE DIAMOND
• Primary DI: D690SW346190M2
• Version / Model: U-SW346-190M
• Catalog Number: SW346190M
• Company Name: Ss White Burs, Inc.
• Labeler DUNS: 151760014
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-02-18
• Public Version: 2
• Public Version Date: 2025-05-06
• Public Version Status: Update
• Public Device Record Key: 9db623e6-4b24-4de6-b485-f3340a2f143a

Device Description

Express Line Diamond Disc Single/Bottom Sided HP 346-190M - 1 PACK

Device Characteristics

• Single Use: No
• 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
DZP	INSTRUMENT, DIAMOND, DENTAL	Dental	872.4535	1

GMDN Terms

Code	Name	Definition	Implantable	Status
34816	Dental laboratory bur	A rotary cutting device made of high-grade steel, the working end of which is made from, or coated with, a hard material (e.g., particles of diamond or tungsten carbide), and which is designed to fit into a dental laboratory handpiece that provides the rotation and that is intended for dental laboratory use only to cut hard structures (e.g., metals, plastics, porcelains), during the fabrication of dental restorations. It is available in various shapes (e.g., cylinder, disk, sphere, oval). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D690SW346190M2	HIBCC

Customer Contacts

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