Duns Number:313785693
Device Description: Colour powder for shade customization and characterization of the surface of dental restor Colour powder for shade customization and characterization of the surface of dental restorations. 2 g bottle.
Catalog Number
M700122
Brand Name
VITA ENAMIC STAIN corn
Version/Model Number
1
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 05, 2022
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
K123761
Product Code
EBD
Product Code Name
Coating, Filling Material, Resin
Public Device Record Key
6766728a-9483-4d0c-9d8a-c4e7fa350822
Public Version Date
August 08, 2022
Public Version Number
4
DI Record Publish Date
October 18, 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 | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |