Duns Number:483599259
Device Description: etkon® iDent Customized abutment Ti, D 4.5/5.0 incl. Ti screw, Compatible with DENTSPLY Im etkon® iDent Customized abutment Ti, D 4.5/5.0 incl. Ti screw, Compatible with DENTSPLY Implants®/ASTRA TECH OsseoSpeed® TX
Catalog Number
2AG023.01
Brand Name
CAD/CAM Abutments
Version/Model Number
1
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 16, 2019
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
NHA
Product Code Name
ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS
Public Device Record Key
3f2e7819-e141-43d8-9fa0-ac31c1aaa4ff
Public Version Date
November 08, 2019
Public Version Number
5
DI Record Publish Date
August 01, 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 | 52 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2726 |
| 3 | A medical device with high risk that requires premarket approval | 5 |