KOMET Dental Ceramic Burs

Basic Information

• Brand Name: KOMET Dental Ceramic Burs
• Primary DI: E226038951A11
• Version / Model: K1SM.205.010.A1
• Catalog Number: K1SM.205.010
• Company Name: Gebr. Brasseler GmbH & Co. KG
• Labeler DUNS: 317409001
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-02-01
• Public Version: 1
• Public Version Date: 2023-02-09
• Public Version Status: New
• Public Device Record Key: 60b3449e-6308-4e97-bc92-f9537f4e4fe6

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: 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: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

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

GMDN Terms

Code	Name	Definition	Implantable	Status
63630	Ceramic dental bur	A rotary cutting device, the working end of which is made from ceramic, designed to fit into a dental handpiece that provides the rotation allowing the user to cut hard structures in the mouth, such as teeth and bone. 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	E226038951A11	HIBCC