Dynamix Speed 2 US

Basic Information

• Brand Name: Dynamix Speed 2 US
• Primary DI: J014660937560
• Version / Model: 66093756
• Catalog Number: 66093756
• Company Name: Kulzer GmbH
• Labeler DUNS: 315666321
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-09-09
• Public Version: 2
• Public Version Date: 2024-10-30
• Public Version Status: Update
• Public Device Record Key: 6f0a8769-d0af-4a64-975e-0c3c53da3451

Device Description

Amalgamator, Dental, AC-Powered

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: 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: 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
38790	Dental impression material mixer	A mains electricity (AC-powered) device designed for mixing to produce a dental impression material chairside immediately before application to the oral cavity of a patient during a dental procedure. It is typically used to blend a salt of alginic acid (i.e., alginate) with water (and appropriate additives if necessary) to produce a dental impression material of rapid irreversible setting. The device typically consists of an electrical mixer with a well, a container (e.g., cup) used to mix the alginate with water before placing in the mixer well, and external controls to operate the mixer.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	J014660937560	HIBCC

Customer Contacts

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