Duns Number:564251911
Device Description: Content: 20 ml Colour Liquid for Prettau® Anterior water-based and acid-free for brush and Content: 20 ml Colour Liquid for Prettau® Anterior water-based and acid-free for brush and dipping technique. Warmer, less greyish colour shades. Every brushstroke before sintering is comprehensible through bio pigments. Use only in combination with metal-free brushes or metal-free tweezers.
Catalog Number
-
Brand Name
Colour Liquid Prettau® Anterior Aquarell Tissue B (20 ml)
Version/Model Number
FMAF5103
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
6d7cfbd1-6f82-4b97-9b50-ef81a879c08e
Public Version Date
January 23, 2019
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 |