AccessGUDID - DEVICE: Minute Stain - L.M.D. Elixirs (D8370125310)

GUDID

Device Identifier (DI) Information

Brand Name: Minute Stain - L.M.D. Elixirs
Version or Model: S/O No. 13 - OR - 6 mL
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 01-2531
Company Name: Taub Products

Primary DI Number: D8370125310
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 067488114 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
45236	Temporary dental crown/bridge resin	A material [e.g., polymethylmethacrylate (PMMA)] intended to make a temporary crown or bridge prosthesis for use until a permanent restoration is fabricated.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EBD	Coating, Filling Material, Resin

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Keep away from open flame. See SDS.

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 6 Milliliter

Device Record Status

Public Device Record Key: b8f215d1-b32d-4bf0-ab8b-5624b7daf474
Public Version Date: July 14, 2025
Public Version Number: 3
DI Record Publish Date: October 11, 2021