Duns Number:636239584
Device Description: Compact Conical Abutment for Ø4.0 Ex Hex, Z-Series, Ø4.8 x 4mm
Catalog Number
-
Brand Name
NA
Version/Model Number
AMCZ4
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
Yes
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
K163634
Product Code
NHA
Product Code Name
Abutment, Implant, Dental, Endosseous
Public Device Record Key
d80de953-2da6-478e-8374-f793fe15b084
Public Version Date
September 01, 2022
Public Version Number
3
DI Record Publish Date
January 23, 2019
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 | 1050 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1479 |