Duns Number:067488114
Device Description: Minute Stain's Larry’s Magical Denture Elixirs or L.M.D. Elixirs, for short, are part of t Minute Stain's Larry’s Magical Denture Elixirs or L.M.D. Elixirs, for short, are part of the Minute Stain line of PMMA denture stains. Developed to work with today’s top 3D Printing Resins and Milled PMMA, L.M.D. Elixirs provide gingival stains that give an excellent match to current denture base shades. Use for Try-Ins, Immediate Load PMMA Temp Dentures, and more. The Elixirs 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
01-2531
Brand Name
Minute Stain - L.M.D. Elixirs
Version/Model Number
S/O No. 13 - OR - 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
b8f215d1-b32d-4bf0-ab8b-5624b7daf474
Public Version Date
October 29, 2021
Public Version Number
2
DI Record Publish Date
October 11, 2021
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 |