Vintage ZR/Vintage Art

Basic Information

• Brand Name: Vintage ZR/Vintage Art
• Primary DI: E2359241TK0
• Version / Model: 001
• Catalog Number: 9241TK
• Company Name: SHOFU DENTAL CORPORATION
• Labeler DUNS: 054618202
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-07-27
• Public Version: 2
• Public Version Date: 2019-12-11
• Public Version Status: Update
• Public Device Record Key: 2b582515-7a95-4c47-8023-791c37e9441c
• Distribution End Date: 2019-12-10

Device Description

One Shot Vintage ZR Trial Kit. Contains DI's: E23590110, E23590130, E23590180, E23590220, E23590270, E23592410, E23565130, E23565140, E23565170, E23565260, E23565270, E23565280, E23565290

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

GMDN Terms

Code	Name	Definition	Implantable	Status
44727	Dental porcelain/ceramic restoration kit	A collection of containers with different shades of porcelain (ceramic based material in powder form) intended to be used in prefabricated and custom-made dental restorations, e.g., artificial teeth on copings, crowns, or bridges. This kit is typically used in the dental laboratory. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	E2359241TK0	HIBCC

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 1 – 30 Degrees Celsius