Duns Number:096010525
Device Description: Eugenol Free Temporary Crown and Bridge Cement in Automix Dispensing System. Zinc Oxide B Eugenol Free Temporary Crown and Bridge Cement in Automix Dispensing System. Zinc Oxide Based. ZNO Aliphatic Acid.
Catalog Number
51-50
Brand Name
SciPharm Eugenone Temporary Cement
Version/Model Number
SP 51-50
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
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
K051952
Product Code
EMA
Product Code Name
Cement, Dental
Public Device Record Key
e01adc10-cf45-4fca-9880-4ab215ac5e11
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 03, 2016
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 | 10 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 476 |