Duns Number:078352849
Device Description: Implant Abutment 3.5mm x 30 degree -5mm Height
Catalog Number
PN35.30S
Brand Name
TatumSurgical/Abutment (Post)
Version/Model Number
Abutment/3.5mm x 30 degree Post - Short
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
K811923
Product Code
NHA
Product Code Name
Abutment, Implant, Dental, Endosseous
Public Device Record Key
e578a9e8-3db2-4ee9-9235-c1177d8d4ad6
Public Version Date
June 18, 2021
Public Version Number
4
DI Record Publish Date
October 30, 2015
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 | 405 |
2 | A medical device with a moderate to high risk that requires special controls. | 536 |