2713 Yellow Ceramic Alloy

Basic Information

• Brand Name: 2713 Yellow Ceramic Alloy
• Primary DI: 00841549100147
• Version / Model: 1069010
• Company Name: STERNGOLD DENTAL LLC
• Labeler DUNS: 124763728
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-02-16
• Public Version: 5
• Public Version Date: 2020-07-09
• Public Version Status: Update
• Public Device Record Key: 040f672c-1bba-4aff-831a-450ea72c32d2

Device Description

High Noble. Ceramic alloy. This is the most noble (thus the most inert) alloy ever offered in the market, 90% gold and 10% platinum. Like our Bio-C, this alloy is soft with a low melting range. It can be used for full-metal as well as ceramic restorations, but is not recommended for bridges. Sterngold's Bio Alloys were developed for those patients who are allergic to conventional dental alloys. To permit restorations to be as inert as possible in the oral cavity, Bio Alloys maximize gold and platinum content (the two most noble elements) and avoid as much as possible those noble elements that are lower in the electromotive series.

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: 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
EJS	Alloy, Other 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	00841549100147	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K962324	000