Duns Number:012430880
Device Description: Zirlux Titanium Abutment 4.5 mmH, Non-Engaging, compatible with: Dentsply Implants Astra T Zirlux Titanium Abutment 4.5 mmH, Non-Engaging, compatible with: Dentsply Implants Astra Tech Implant System 3.5/4.0
Catalog Number
9012232
Brand Name
Zirlux
Version/Model Number
9012232
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
NHA
Product Code Name
ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS
Public Device Record Key
3967234f-ef7a-47ef-a156-aacc616ba2bd
Public Version Date
November 08, 2019
Public Version Number
4
DI Record Publish Date
September 24, 2016
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 |
|---|---|---|
| 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 |