Harmony XH - IVOCLAR VIVADENT, INC.

Duns Number:176935203

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More Product Details

Catalog Number

584080

Brand Name

Harmony XH

Version/Model Number

584080

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 03, 2019

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

EJS

Product Code Name

ALLOY, OTHER NOBLE METAL

Device Record Status

Public Device Record Key

6b83bf01-4085-4b11-9679-b0ad61f08ee4

Public Version Date

February 07, 2019

Public Version Number

4

DI Record Publish Date

January 27, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"IVOCLAR VIVADENT, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 21
2 A medical device with a moderate to high risk that requires special controls. 485