Duns Number:124763728
Device Description: TRU Prosthetic Screw NP .048" Hex. The TRU Prosthetic Screws are intended for fixation of TRU Prosthetic Screw NP .048" Hex. The TRU Prosthetic Screws are intended for fixation of abutment to dental implant. They are made from titanium 6AL-4V ELI material.
Catalog Number
-
Brand Name
TRU® Prosthetic Screw NP .050" Hex, Ti
Version/Model Number
904656
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
K150968
Product Code
NHA
Product Code Name
Abutment, Implant, Dental, Endosseous
Public Device Record Key
acd970f3-4f8a-4db5-b326-215277f559b1
Public Version Date
June 08, 2020
Public Version Number
1
DI Record Publish Date
May 29, 2020
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 | 16 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1346 |