Duns Number:124763728
Device Description: Intended for use with Stern IC dental implants to support and/or retain removable dental p Intended for use with Stern IC dental implants to support and/or retain removable dental prostheses in the treatment of partially or totally edentulous patients to restore chewing function. The abutment screws directly into endosseous implants or they screw into Abutment Bases which are screwed into endosseous implants.
Catalog Number
-
Brand Name
Stern IC RN Solid Abutment 4.0mm, Biomain
Version/Model Number
904701
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 09, 2021
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
K111798
Product Code
NHA
Product Code Name
Abutment, Implant, Dental, Endosseous
Public Device Record Key
06f5c41f-0af0-4ec0-a48b-f74338d227b4
Public Version Date
August 10, 2021
Public Version Number
7
DI Record Publish Date
June 20, 2017
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 | 16 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1346 |