MEDENTiKA

Basic Information

• Brand Name: MEDENTiKA
• Primary DI: 04251574822987
• Version / Model: M 74
• Catalog Number: M 74
• Company Name: MEDENTiKA GmbH
• Labeler DUNS: 537555497
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-04-26
• Public Version: 1
• Public Version Date: 2022-05-04
• Public Version Status: New
• Public Device Record Key: ec74368a-437e-4ac9-811a-72c4e0a8cbac

Device Description

Thread cleaner

Device Characteristics

• Single Use: Yes
• 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: MR Conditional
• Direct Marking Exempt: No
• 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
NDP	Accessories, implant, dental, endosseous	Dental	872.3980	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64528	Dental implant internal thread shaping tool	A cylindrical rod with a spiralled cutting distal end, similar to a drill bit or a screw, intended to be used to shape and rectify the internal thread of a dental implant that has been implanted into bone. It is made of metal and is designed to be attached to a manual screwdriver. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	EMKAM749	HIBCC
Primary	04251574822987	GS1

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Compatible with Medentika