Duns Number:534128491
Device Description: Temporary PEEK Anatomic Anti Rotation Abutment 3.75 mm Diameter,
Catalog Number
P3S-Peek-3.75,2
Brand Name
Prosthetic Accessories
Version/Model Number
P3S-PEEK-3.75,2
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
K132125,K132125,K132125
Product Code
NHA
Product Code Name
Abutment, Implant, Dental, Endosseous
Public Device Record Key
27900069-cb43-4171-b585-b9ad674a4b13
Public Version Date
January 14, 2020
Public Version Number
2
DI Record Publish Date
July 07, 2019
Package DI Number
17290107278512
Quantity per Package
10
Contains DI Package
07290107278515
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
beg
| 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 |