Jensen Premium Dental Alloy - JENSEN INDUSTRIES INC.

Duns Number:060018587

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More Product Details

Catalog Number

5243C

Brand Name

Jensen Premium Dental Alloy

Version/Model Number

BLAZE 5dwt

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

542ec908-6e4c-4173-80df-51fd9c2c2a7b

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"JENSEN INDUSTRIES INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 364