Duns Number:067488114
Device Description: Tru-Stains are colored acrylic powder, that are applied by brush to modify the shades of p Tru-Stains are colored acrylic powder, that are applied by brush to modify the shades of provisional and permanent acrylic. The stains are applied to heat cured acrylic restorations.
Catalog Number
01-2925
Brand Name
Tru-Stain
Version/Model Number
Blue - 3 gm
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
Yes
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
EBD
Product Code Name
Coating, Filling Material, Resin
Public Device Record Key
54589d12-c1d7-41b7-b349-34bd37983fb1
Public Version Date
October 29, 2021
Public Version Number
3
DI Record Publish Date
December 19, 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 | 28 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 130 |