Duns Number:055605664
Device Description: Titanium Abutment, 4.3mm, 7.0mm height x 1.5mm gum height
Catalog Number
-
Brand Name
Zuga
Version/Model Number
TAA-430-170
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
K122664
Product Code
NHA
Product Code Name
Abutment, Implant, Dental, Endosseous
Public Device Record Key
8ab1c301-5d59-45f7-b298-06653f3e3646
Public Version Date
November 08, 2019
Public Version Number
5
DI Record Publish Date
January 16, 2018
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 | 27 |
2 | A medical device with a moderate to high risk that requires special controls. | 153 |