Duns Number:312649568
Device Description: 6,0 x 6,0mm Gingiva Former w/ 3mm Post
Catalog Number
TA 60060+NH/3
Brand Name
K3Pro Konus Dental Implants
Version/Model Number
TA 60060+NH/3
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
K141159
Product Code
NHA
Product Code Name
Abutment, Implant, Dental, Endosseous
Public Device Record Key
ccb070fe-bfae-4530-9896-3d0ee5681d44
Public Version Date
December 07, 2018
Public Version Number
4
DI Record Publish Date
September 02, 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 | 65 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 267 |