Caulk® Super Bur®

Basic Information

• Brand Name: Caulk® Super Bur®
• Primary DI: D0026657681
• Version / Model: 665768
• Catalog Number: 665768
• Company Name: DENTSPLY INTERNATIONAL INC.
• Labeler DUNS: 083235549
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2019-04-02
• Public Version: 2
• Public Version Date: 2020-03-23
• Public Version Status: Update
• Public Device Record Key: a875c1b7-8997-43cb-9585-c0809f7769e2

Device Description

Caulk Super Bur 10-Pack - Size 701XL FG

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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EJL	BUR, DENTAL	Dental	872.3240	1

GMDN Terms

Code	Name	Definition	Implantable	Status
16668	Carbide dental bur, reusable	A rotary cutting device made of high-grade steel, the working end of which is made from, or coated with, tungsten carbide, and which is designed to fit into a dental handpiece that provides the rotation allowing the user to cut hard structures in the mouth, e.g., teeth or bone. It can also be used to cut hard metals, plastics, porcelains and similar materials. 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	D0026657681	HIBCC
Unit of Use	D0026657680	HIBCC

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			10x Burs - Size 701XL FG Super Bur

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep devices in sterilization packaging in a dry and clean environment.