Duns Number:320744915
Device Description: Light-curing compomer base liner. Gap-free restorations. Content: 10 saferinges @ 0,3 g.
Catalog Number
210911
Brand Name
Ionosit Baseliner
Version/Model Number
210911
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
-
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
K935689,K935689,K935689
Product Code
EBD
Product Code Name
Coating, Filling Material, Resin
Public Device Record Key
f0e4848a-c82e-4a96-9d2d-f060ec551b14
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 21, 2016
Package DI Number
EDMG2109118
Quantity per Package
12
Contains DI Package
EDMG2109111
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 24 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 143 |