Harvard Polycarboxylat Cement, Clinic liquid - Zinc polycarboxylate cement - Harvard Dental International GmbH

Duns Number:341553293

Device Description: Zinc polycarboxylate cement

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More Product Details

Catalog Number

-

Brand Name

Harvard Polycarboxylat Cement, Clinic liquid

Version/Model Number

7031300

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

Prescription Use (Rx)

Yes

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

a8234246-0972-4018-b7e8-3e79e91bb699

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 11, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HARVARD DENTAL INTERNATIONAL GMBH" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 131