Duns Number:320744915
Device Description: Temporary cement smartmix system. Invisible under restorations, yet detectable for excess Temporary cement smartmix system. Invisible under restorations, yet detectable for excess removal. Content: 1 syringe @ 5ml, Accessories.
Catalog Number
213200
Brand Name
TempoCemID
Version/Model Number
213200
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
K160443,K160443,K160443
Product Code
EMA
Product Code Name
Cement, Dental
Public Device Record Key
ab316d19-fd98-4358-9246-a7f6c19900f4
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
March 08, 2017
Package DI Number
EDMG2132008
Quantity per Package
12
Contains DI Package
EDMG2132001
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 |