Duns Number:564251911
Device Description: Compatible with ASTRA TECH Implant System EV _ UniAbutment EV implants White Metal Scanma Compatible with ASTRA TECH Implant System EV _ UniAbutment EV implants White Metal Scanmarker consisting of: 1x White Metal Scanmarker L12 1x White Metal Scanmarker Screw
Catalog Number
-
Brand Name
ZZ BASE AS-EV-WMSM-L12 5.4 (White Metal Scanmarker L12 with Screw)
Version/Model Number
ZBED7635L12
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
-
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
NDP
Product Code Name
Accessories, implant, dental, endosseous
Public Device Record Key
faa96c7c-7393-4041-89d8-5ded5576209f
Public Version Date
October 05, 2021
Public Version Number
1
DI Record Publish Date
September 27, 2021
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 | 1369 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4845 |
| U | Unclassified | 3 |