ProSilver - Dental amalgam powder - SILMET LTD

Duns Number:600071344

Device Description: Dental amalgam powder

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More Product Details

Catalog Number

-

Brand Name

ProSilver

Version/Model Number

P-110140

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

EJJ

Product Code Name

Alloy, Amalgam

Device Record Status

Public Device Record Key

0030480d-675a-49e6-8148-9fceebd3336b

Public Version Date

January 03, 2022

Public Version Number

5

DI Record Publish Date

October 22, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SILMET LTD" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 278