Duns Number:694721181
Device Description: Dental Implant System / s-Clean FreeMill Abutment Set (Abutment + Abutment Screw)
Catalog Number
-
Brand Name
s-Clean FreeMill Abutment
Version/Model Number
DSFMA7520HS
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
K111364
Product Code
NHA
Product Code Name
Abutment, Implant, Dental, Endosseous
Public Device Record Key
bafd0020-29ce-4901-81c5-56c1cf830a4a
Public Version Date
May 26, 2021
Public Version Number
4
DI Record Publish Date
May 31, 2019
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 | 1118 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4011 |