Sterngold® 100 - Type V Yellow Crown & Bridge Alloy - High Noble. Type IV crown and bridge alloy. Bio-H - STERNGOLD DENTAL LLC

Duns Number:124763728

Device Description: High Noble. Type IV crown and bridge alloy. Bio-H is extra hard. When heat treated its Vic High Noble. Type IV crown and bridge alloy. Bio-H is extra hard. When heat treated its Vickers value is 290. It also has good yield strength and can be used for bridges and removable partial denture frameworks.

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More Product Details

Catalog Number

-

Brand Name

Sterngold® 100 - Type V Yellow Crown & Bridge Alloy

Version/Model Number

1126040

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

EJT

Product Code Name

Alloy, Gold-Based Noble Metal

Device Record Status

Public Device Record Key

14ed98c8-5a24-4760-9455-8927957ec6be

Public Version Date

February 24, 2021

Public Version Number

2

DI Record Publish Date

May 27, 2020

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