DEVICE: Glaze (D8370170020)

Device Identifier (DI) Information

Glaze
Liquid - 16 oz
In Commercial Distribution
01-7002
Taub Products
D8370170020
HIBCC

1
067488114 *Terms of Use
Glaze contains a translucent acrylic and thinner that gives a gloss coating to provisional and permanent acrylic, and composite restorations. Glaze is quick setting and cures and bonds 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
No
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

[?]
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: 16 Fluid Ounce
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Device Record Status

1dd449bd-ac1d-4444-8609-dd76e6bf69c5
March 29, 2018
2
October 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

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

[?]
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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