ProGlass Two LC - Dental Glass Ionomer Cement - SILMET LTD

Duns Number:600071344

Device Description: Dental Glass Ionomer Cement

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More Product Details

Catalog Number

172B02-LC

Brand Name

ProGlass Two LC

Version/Model Number

172B02-LC

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

EMA

Product Code Name

Cement, Dental

Device Record Status

Public Device Record Key

aa44dbf5-2817-41d1-be33-d39252d166a8

Public Version Date

January 03, 2022

Public Version Number

5

DI Record Publish Date

December 15, 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