Dentorium - Bonding Alloy - WRIGHT HEALTH GROUP LIMITED

Duns Number:214045304

Device Description: Bonding Alloy

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More Product Details

Catalog Number

AL104KG

Brand Name

Dentorium

Version/Model Number

Chrome Cobalt Alloy Shot 4 kg

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)

-

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

EJH

Product Code Name

Alloy, Metal, Base

Device Record Status

Public Device Record Key

20be400c-569d-48ae-a8ee-26514957ac2c

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 01, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"WRIGHT HEALTH GROUP LIMITED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 10
2 A medical device with a moderate to high risk that requires special controls. 4230