Vista White Ceramic Alloy

Basic Information

• Brand Name: Vista White Ceramic Alloy
• Primary DI: 00841549100024
• Version / Model: 1060005
• Company Name: STERNGOLD DENTAL LLC
• Labeler DUNS: 124763728
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-03-10
• Public Version: 4
• Public Version Date: 2020-07-09
• Public Version Status: Update
• Public Device Record Key: 3ba4d09c-22df-488f-a19b-719ae08f4100

Device Description

Noble. Palladium-silver alloy. A super economy ceramic alloy. More restorations have been fabricated using Vista than any other precious Sterngold alloy. More than 2 million units in the mouth testify to its popularity. It casts and polishes like a conventional ceramic gold. Vista contains more than 60% noble metal and resists tarnishing on exposed surfaces.

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: Yes
• 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
EJT	Alloy, Gold-Based Noble Metal	Dental	872.3060	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35858	Dental casting noble alloy	A material composed primarily of noble metals [e.g., gold (Au), palladium (Pd), platinum (Pt), or silver (Ag)] intended for use in the fabrication of a dental cast [i.e., a positive copy of a part of the oral anatomy made in an impression (mould), such as a dental crown] or dental restorations and appliances (e.g., porcelain-fused-to-metal crowns and bridge restorations). It is typically available in the form of small ingots or bars that are melted and poured into an impression. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00841549100024	GS1

Customer Contacts

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