Duns Number:482083990
Device Description: SICvantage Standard Abutment blue, posterior, 15° angle, GH 5.0 mm (incl. SIC Standard Fix SICvantage Standard Abutment blue, posterior, 15° angle, GH 5.0 mm (incl. SIC Standard Fixation Screw and Impression Cap)
Catalog Number
-
Brand Name
SIC invent Dental Implant Systems
Version/Model Number
950633
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
93a9378a-c92a-4073-936d-df795972f4b7
Public Version Date
November 08, 2019
Public Version Number
2
DI Record Publish Date
August 28, 2018
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 281 |