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
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
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
DZE
Product Code Name
Implant, Endosseous, Root-Form
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
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 260 |