Duns Number:320744915
Device Description: Temporary cement automix system. The temporary cement that keeps its promise. Content: 2 s Temporary cement automix system. The temporary cement that keeps its promise. Content: 2 syringes @ 5 ml paste, accessories.
Catalog Number
212129
Brand Name
TempoCem® Automix
Version/Model Number
212129
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
K110759,K110759,K110759
Product Code
EMB
Product Code Name
Zinc Oxide Eugenol
Public Device Record Key
b97f0724-2dc7-4ce1-ab67-7c1f9224e3fc
Public Version Date
November 17, 2020
Public Version Number
1
DI Record Publish Date
November 09, 2020
Package DI Number
EDMG2121291
Quantity per Package
2
Contains DI Package
EDMG2121290
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 |