Duns Number:320744915
Device Description: Temporary cement automix system, eugenol free. The temporary cement that keeps its promise Temporary cement automix system, eugenol free. The temporary cement that keeps its promise. Content: 2 syringes @ 5 ml paste, accessories.
Catalog Number
212104
Brand Name
TempoCem®NE Smartmix
Version/Model Number
212104
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
K970774,K970774,K970774
Product Code
EMA
Product Code Name
Cement, Dental
Public Device Record Key
67a1abb0-c393-41d8-aff4-5a1ea2bdcb71
Public Version Date
November 17, 2020
Public Version Number
1
DI Record Publish Date
November 09, 2020
Package DI Number
EDMG2121041
Quantity per Package
2
Contains DI Package
EDMG2121040
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 |