Duns Number:564251911
Device Description: Content: 1 g Three-dimensional stain colours with special depth effect for surface colouri Content: 1 g Three-dimensional stain colours with special depth effect for surface colouring of full zirconia, ceramics and press ceramic. Stain and glaze firing can also be done in one step by working with the glazing mass directly on the case.
Catalog Number
-
Brand Name
Stain Colour 3D Base D (1 g)
Version/Model Number
MFAC1901
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
-
Product Code
EIH
Product Code Name
POWDER, PORCELAIN
Public Device Record Key
f117a6a2-81f4-4d7b-b2c1-7bc42962135b
Public Version Date
July 24, 2018
Public Version Number
3
DI Record Publish Date
November 04, 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 | 1369 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4845 |
| U | Unclassified | 3 |