Duns Number:689667152
Device Description: Screw Abutment Titanium Cylinder Φ4.0 SingleIt is One-piece Cylinder. The bottom part is d Screw Abutment Titanium Cylinder Φ4.0 SingleIt is One-piece Cylinder. The bottom part is designed to be connected with screw abutment head part. Screw Abutment Screw (SAS18) is used to connect.
Catalog Number
-
Brand Name
SIS (Luna)
Version/Model Number
STC40S
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
K123155,K123155
Product Code
NHA
Product Code Name
Abutment, Implant, Dental, Endosseous
Public Device Record Key
7f0ddd64-39e1-42ef-b3f7-2bded809fae8
Public Version Date
July 28, 2020
Public Version Number
4
DI Record Publish Date
August 31, 2015
Package DI Number
18809458316775
Quantity per Package
12
Contains DI Package
08809458316778
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 542 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 133 |