Sterngold S - High Noble. Ceramic alloy. This is the most noble - STERNGOLD DENTAL LLC

Duns Number:124763728

Device Description: High Noble. Ceramic alloy. This is the most noble (thus the most inert) alloy ever offered 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.

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More Product Details

Catalog Number

-

Brand Name

Sterngold S

Version/Model Number

1128386

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

EJS

Product Code Name

Alloy, Other Noble Metal

Device Record Status

Public Device Record Key

87de9c42-e5e9-40a8-8a4d-17ce8ccdb69a

Public Version Date

February 23, 2021

Public Version Number

1

DI Record Publish Date

February 15, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"STERNGOLD DENTAL LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 16
2 A medical device with a moderate to high risk that requires special controls. 1346