DEVICE: Tru-Stain (D8370129000)

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Device Identifier (DI) Information

Tru-Stain
Yellow - 3 gm
01-2900
Taub Products
D8370129000
HIBCC
1
Tru-Stains are colored acrylic powder, that are applied by brush to modify the shades of provisional and permanent acrylic. The stains are applied to heat cured acrylic restorations.
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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

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

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Size Type Text
Weight: 3 Gram
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Device Status

In Commercial Distribution
December 19, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
No
No
No CLOSE

Customer Contact

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+1.201.798.5353
customerservice@taubdental.com
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