DEVICE: Minute Stain (D8370145010)

Device Identifier (DI) Information

Minute Stain
Thinner for Brush - 25 mL (1 oz)
In Commercial Distribution
01-4501
Taub Products
D8370145010
HIBCC

1
067488114 *Terms of Use
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.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
No
Yes
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Dental crown/bridge resin, temporary A material [e.g., polymethylmethacrylate (PMMA)] intended to make a temporary crown or bridge prosthesis for use until a permanent restoration is fabricated.
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FDA Product Code

[?]
Product Code Product Code Name
EBD Coating, Filling Material, Resin
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FDA Premarket Submission

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

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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

[?]
Size Type Text
Total Volume: 25 Milliliter
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Device Record Status

ad918f56-0953-41f5-844e-18772a269658
March 29, 2018
2
December 19, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
+1.201.798.5353
customerservice@taubdental.com
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