Duns Number:689667152
Device Description: Dental Implant System is intended to be surgically placed in the bone of the upper or lowe Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing fuction.
Catalog Number
-
Brand Name
SIS(Luna)
Version/Model Number
NSIR5015S
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
200df8a0-e6ef-4a7b-af1e-94f8d2cab771
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 10, 2016
Package DI Number
18809457201546
Quantity per Package
20
Contains DI Package
08809457201549
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 |