MK-dent

Basic Information

• Brand Name: MK-dent
• Primary DI: E490AM10061
• Version / Model: ACCESSORIES
• Catalog Number: AM1006
• Company Name: MK-Dent GmbH
• Labeler DUNS: 343618943
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-10-14
• Public Version: 1
• Public Version Date: 2024-10-22
• Public Version Status: New
• Public Device Record Key: ea70933f-7a28-46bc-be47-0a3af58cd737

Device Description

Air Motor

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• 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
EFB	Handpiece, Air-Powered, Dental	Dental	872.4200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
66228	Dental surgical power tool motor, pneumatic	A hand-held, pneumatically-powered component of a surgical power tool assembly designed to convert the energy from a compressed gas source [e.g., surgical-grade air or nitrogen (N2)] into a non-dedicated mechanical energy for drilling or sawing during dental surgery. It is designed to accept handpiece components/attachments (not included) and is not intended to directly accept an endpiece (e.g., drill bit, saw blade). It might be operated with a hand- or foot-switch. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	E490AM10061	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K051872	000