Duns Number:526885184
Device Description: A device used to mix the powder and liquid in application capsules intended for use in den A device used to mix the powder and liquid in application capsules intended for use in dental treatments.
Catalog Number
Y200F6D490 9050
Brand Name
VOCO GIC Mixer
Version/Model Number
A
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EFD
Product Code Name
Amalgamator, Dental, Ac-Powered
Public Device Record Key
0c6ee46f-c226-4305-87d8-64cfbad97ccb
Public Version Date
April 19, 2022
Public Version Number
1
DI Record Publish Date
April 11, 2022
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 | 1 |