Parkell®

Basic Information

• Brand Name: Parkell®
• Primary DI: 10810000527752
• Version / Model: SDS-834-016M
• Catalog Number: SDS-834-016M
• Company Name: PARKELL, INC.
• Labeler DUNS: 009900424
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2019-07-26
• Public Version: 5
• Public Version Date: 2023-12-27
• Public Version Status: Update
• Public Device Record Key: 64a38611-812e-44a4-81c5-9b66c3d496a3
• Distribution End Date: 2023-04-24

Device Description

834-016M Sterile FG Diamond Burs, Tri-Wheel Depth Cutter, Medium Grit

Device Characteristics

• Single Use: Yes
• 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: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• 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
45525	Diamond dental bur, single-use	A rotary cutting device made of high-grade steel with the working end coated with particles of diamond, and which is designed to fit into a dental handpiece that provides the rotation allowing the user to cut hard structures in the mouth, such as teeth or bone. It can also be used to cut hard metals, plastics, porcelains and similar materials intended for use in the fabrication of dental devices. It is available in various shapes (e.g., cylinder, disk, sphere, oval). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10810000527752	GS1
Unit of Use	00810000527755	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Outer Diameter	1.6	Millimeter
Length	6.0	Millimeter