IPS Empress CAD - materials for inlays, onlays, crowns and bridges - IVOCLAR VIVADENT AKTIENGESELLSCHAFT

Duns Number:448015938

Device Description: materials for inlays, onlays, crowns and bridges

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More Product Details

Catalog Number

665758

Brand Name

IPS Empress CAD

Version/Model Number

665758

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

Yes

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

EIH

Product Code Name

POWDER, PORCELAIN

Device Record Status

Public Device Record Key

974ca8b6-bcc1-4c87-ae53-9ad4fd4e324f

Public Version Date

July 24, 2018

Public Version Number

3

DI Record Publish Date

December 07, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"IVOCLAR VIVADENT AKTIENGESELLSCHAFT" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 131
2 A medical device with a moderate to high risk that requires special controls. 12768