Duns Number:067488114
Device Description: Minute Stains are quick setting colored acrylic liquids that are applied by brush to modif Minute Stains are quick setting colored acrylic liquids that are applied by brush to modify the shades of provisional and permanent acrylic and composite restorations. The stains cure and bond to all dental resins, including ethyl and methyl methacrylates, bis-acryl resins, polycarbonates, vinyl methacrylate copolymers, resin crowns and laminates, denture base, acrylic denture teeth and composite resins.
Catalog Number
01-2125
Brand Name
Minute Stain
Version/Model Number
Brown/Red - Dark - 6 mL
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
c81158a6-817e-4c7f-8af1-686a4773b6e5
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 |