RotoMix™

Basic Information

• Brand Name: RotoMix™
• Primary DI: J001702011022020
• Version / Model: 76310
• Catalog Number: 76310
• Company Name: 3M Deutschland GmbH
• Labeler DUNS: 315731711
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: aadd85b6-92af-4447-ae9e-d3a993642ed0

Device Description

3M™ ESPE™ Rotomix™ Capsule Mixing Unit, 120V/60Hz, 76310

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: 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: Yes
• Has Manufacturing Date: No
• 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
EFD	AMALGAMATOR, DENTAL, AC-POWERED	Dental	872.3100	1

GMDN Terms

Code	Name	Definition	Implantable	Status
10082	Dental amalgam mixer	A mains electricity (AC-powered) device used to shake a homogenous mixture of fine dental alloy particles [e.g., tin (Sn), silver (Ag), zinc (Zn), or copper (Cu)] with mercury (Hg) to obtain a dental amalgam, typically right before application. The amalgam is usually prepared in an appropriate capsule that may or may not be an integral part of the device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	J001702011022020	HIBCC

Customer Contacts

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