ProSilver - Dental Amalgam - SILMET LTD

Duns Number:600071344

Device Description: Dental Amalgam

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More Product Details

Catalog Number

P-110150

Brand Name

ProSilver

Version/Model Number

P-110150

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

9cb88a5f-2e33-4792-b022-a5f94ec3eb31

Public Version Date

January 03, 2022

Public Version Number

5

DI Record Publish Date

November 09, 2016

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