Duns Number:534128491
Device Description: Wide Angular Abutment Angular Ball Attachment 20 degree - 1.5 mm
Catalog Number
P5-3,20-1.5
Brand Name
Prosthetic Accessories
Version/Model Number
P5-3,20-1.5
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
-
Product Code
DZE
Product Code Name
Implant, Endosseous, Root-Form
Public Device Record Key
bca051f0-5e5b-4b5d-add4-e0ac9a71d4a8
Public Version Date
October 07, 2019
Public Version Number
1
DI Record Publish Date
September 29, 2019
Package DI Number
17290111273619
Quantity per Package
10
Contains DI Package
07290111273612
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
bag
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 190 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 276 |