KOHDENT

Basic Information

• Brand Name: KOHDENT
• Primary DI: 04251436932137
• Version / Model: 8421
• Catalog Number: 8421
• Company Name: Kohdent Roland Kohler Medizintechnik GmbH & Co. KG
• Labeler DUNS: 324006097
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-08-30
• Public Version: 1
• Public Version Date: 2021-09-07
• Public Version Status: New
• Public Device Record Key: 7dd675ca-44df-484b-ab56-33e534e21715

Device Description

MTA carver CLEE acc. to Dr. Lee TRINOVO PEEK black ENDOBLACK

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: Yes
• 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: 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
HXR	SPATULA, ORTHOPEDIC	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
38530	Dental spatula, reusable	A hand-held manual dental device used to manipulate filling materials in the plastic state. It is typically made of stainless steel with a small, flat, blunt blade (no sharp edges) at one end, or it may be double-ended. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04251436932137	GS1

Customer Contacts

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