Spherodon + - Dental Amalgam Alloy - SILMET LTD

Duns Number:600071344

Device Description: Dental Amalgam Alloy

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More Product Details

Catalog Number

139491

Brand Name

Spherodon +

Version/Model Number

139491

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

9c2d6e6a-0621-40f3-9399-fb1f332fd0d7

Public Version Date

January 03, 2022

Public Version Number

5

DI Record Publish Date

October 26, 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