Duns Number:689667152
Device Description: Dental Implant System is intended to be surgically placed in the bone of the upper or lowe
Catalog Number
-
Brand Name
SIS(Luna)
Version/Model Number
NSIR6011SF
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
K160106,K160106
Product Code
DZE
Product Code Name
Implant, Endosseous, Root-Form
Public Device Record Key
6ab0429c-ef49-4bd3-9a7c-73d60b6c3ebf
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 10, 2016
Package DI Number
18809457201911
Quantity per Package
20
Contains DI Package
08809457201914
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 |