Axiom - Axiom implant PX Ø3.4 x 16.0,Replacement of a - ETABLISSEMENTS ANTHOGYR

Duns Number:275978864

Device Description: Axiom implant PX Ø3.4 x 16.0,Replacement of a missing tooth for placement of a dental rest Axiom implant PX Ø3.4 x 16.0,Replacement of a missing tooth for placement of a dental restoration, not usable in the molar area, not recommended in D1 bone

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More Product Details

Catalog Number

PX34160

Brand Name

Axiom

Version/Model Number

PX34160

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)

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

DZE

Product Code Name

Implant, Endosseous, Root-Form

Device Record Status

Public Device Record Key

f7d8d912-6032-46d6-8128-8f29807c6363

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

June 22, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ETABLISSEMENTS ANTHOGYR" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 260