Viva-mate 3

Basic Information

• Brand Name: Viva-mate 3
• Primary DI: 04560264572638
• Version / Model: Viva-mate 3 Charger (120V)
• Company Name: NAKANISHI INC.
• Labeler DUNS: 690710546
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-08-19
• Public Version: 2
• Public Version Date: 2023-10-12
• Public Version Status: Update
• Public Device Record Key: 3ced052f-94d1-49e1-a600-34e62c5677bb

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: No
• 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
EKX	Handpiece, direct drive, ac-powered	Dental	872.4200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
41264	Surgical power tool system control unit, line-powered	A mains electricity (AC-powered) component of a line-powered surgical/dental power tool system intended to step down the electrical power from the mains to supply the handpiece/motor (not included), and may also be intended to regulate some of the functions of the connected power tools (e.g., speed and torque); it may be intended for single or multiple clinical applications (i.e., dedicated or non-dedicated). This device may have integrated irrigation functionality and may be operated through hand and/or foot controls.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04560264572638	GS1

Premarket Submissions

Submission Number	Supplement Number
K990646	000