MEDENTiKA

Basic Information

• Brand Name: MEDENTiKA
• Primary DI: 04251574822871
• Version / Model: M 34
• Catalog Number: M 34
• 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: 2
• Public Version Date: 2022-06-17
• Public Version Status: Update
• Public Device Record Key: 90c93b93-5efa-4ba0-9a42-c295e02497c5

Device Description

Loosening tool

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
64422	Dental prosthesis removal instrument	A non-electric, hand-held dental instrument intended to be used to remove a permanent or temporary cemented dental prosthesis restoration (e.g., crown, denture, bridge) from a tooth or implant abutment; it is not a thermal detacher. It consists of a metallic instrument with a handle and a pointed, angled distal end used to secure the instrument at the margin of the prosthesis to be removed; it may be designed as a manual, pneumatic or spring-loaded instrument whereby light force is applied to detach the restoration. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	EMKAM349	HIBCC
Primary	04251574822871	GS1

Device Sizes

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