DEVICE: Therma Cure (D798TC0)

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Device Identifier (DI) Information

Therma Cure
TC
TC
RELIANCE ORTHODONTIC PRODUCTS INC
D798TC0
HIBCC
1
Therma-Cure is intended for use as a heat curable adhesive for indirect bonding.
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Device Characteristics

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

GMDN

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

GMDN Preferred Term Name GMDN Definition
Denture base resin kit, heat-cured A collection of resins and other devices and/or materials intended to be used in the dental laboratory to manufacture a complete or partial denture base (the portion of a denture that rests on the oral mucosa and retains the artificial teeth) using resins that polymerize with heat. It usually includes the resin monomer (typically an acrylic monomer of methyl methacrylate) and a catalyst intended for polymerization of the monomer; it also includes other products such as pigments, plasticizers, and/or devices (e.g., flasks, clamps). This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
DYH Adhesive, Bracket And Tooth Conditioner, 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: Store at room temperature (15-30 degrees C.)
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
July 27, 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
Yes
No
No CLOSE

Customer Contact

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630-773-4009
paulgropi@aol.com
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