AccessGUDID - DEVICE: Minute Stain (D8370145010)

GUDID

Device Identifier (DI) Information

Brand Name: Minute Stain
Version or Model: Thinner for Brush - 25 mL (1 oz)
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 01-4501
Company Name: Taub Products

Primary DI Number: D8370145010
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 067488114 *Terms of Use

Device Description: Minute Stain Thinner is used to refill thinner in a bottle of Minute Stain color, where the thinner has evaporated over time and / or the user wants to change the viscosity and / or create a custom color and / or extend working time and / or clean applicator brush. 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.

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: 25 Milliliter

Device Record Status

Public Device Record Key: ad918f56-0953-41f5-844e-18772a269658
Public Version Date: October 29, 2021
Public Version Number: 3
DI Record Publish Date: December 19, 2016