Duns Number:316699578
Device Description: Glass ionomer luting cement.Low solubility in the mouth.Low acidity.Biocompatible.Easy app Glass ionomer luting cement.Low solubility in the mouth.Low acidity.Biocompatible.Easy application.
Catalog Number
1086
Brand Name
Meron
Version/Model Number
1086
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
-
Product Code
EMA
Product Code Name
Cement, Dental
Public Device Record Key
896d2c4e-129d-4e6e-b553-6b82b7edebb3
Public Version Date
May 30, 2019
Public Version Number
1
DI Record Publish Date
May 22, 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 | 40 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 396 |
| U | Unclassified | 5 |