Zirlux - Zirlux Titanium Abutment 4.5 mmH, Non-Engaging, - HENRY SCHEIN, INC.

Duns Number:012430880

Device Description: Zirlux Titanium Abutment 4.5 mmH, Non-Engaging, compatible with: Nobel Biocare NobelReplac Zirlux Titanium Abutment 4.5 mmH, Non-Engaging, compatible with: Nobel Biocare NobelReplace NP

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More Product Details

Catalog Number

9012215

Brand Name

Zirlux

Version/Model Number

9012215

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

NHA

Product Code Name

ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Device Record Status

Public Device Record Key

d7512ca0-534e-4b5b-988b-dccef141b971

Public Version Date

November 08, 2019

Public Version Number

4

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HENRY SCHEIN, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3829
2 A medical device with a moderate to high risk that requires special controls. 2579
3 A medical device with high risk that requires premarket approval 1
U Unclassified 34