Dimanto

Basic Information

• Brand Name: Dimanto
• Primary DI: E22123801
• Version / Model: 2380
• Catalog Number: 2380
• Company Name: VOCO GmbH
• Labeler DUNS: 316699578
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2019-06-06
• Public Version: 3
• Public Version Date: 2020-03-23
• Public Version Status: Update
• Public Device Record Key: f6287790-2aec-41cc-81d7-1f30ad1270ef

Device Description

Dimanto is a one-step polishing system for pre-polishing and highgloss polishing finished composite restorations. The diamondinterspersed silicone polishers are suitable for repeated use.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EHJ	Disk, Abrasive	Dental	872.6010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35807	Dental abrasive disk, reusable	A dental instrument consisting of a circular flat or slightly conical sheet carrying or containing an abrasive, intended to perform a circular and/or oscillatory motion for polishing and finishing a cavity preparation and/or for cutting or polishing dental restorations. It is designed to be fixed at its centre to a mandrel and intended to be used with a dental power tool handpiece (e.g., straight or contra-angle). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	E22123801	HIBCC
Unit of Use	E2212380	HIBCC

Customer Contacts

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