Duns Number:322018193
Device Description: Titanium cap for bar abutment, for bridge, incl. prosthetic screw, light blue anodized, fo Titanium cap for bar abutment, for bridge, incl. prosthetic screw, light blue anodized, for Ø 5.0/6.0 mm, titanium alloy
Catalog Number
J2259.6002
Brand Name
Titanium cap for bar abutment, for bridge
Version/Model Number
J2259.6002
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
NHA
Product Code Name
Abutment, Implant, Dental, Endosseous
Public Device Record Key
e7e056e3-6ef1-411d-99cd-acc1e72cce9e
Public Version Date
November 08, 2019
Public Version Number
4
DI Record Publish Date
February 12, 2016
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 | 290 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 901 |