DEVICE: Excel (D798EHJF0)

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Device Identifier (DI) Information

Excel
EHJF
EHJF
RELIANCE ORTHODONTIC PRODUCTS INC
D798EHJF0
HIBCC
1
Excel Herbst Kit is intended for use as an orthodontic bonding adhesive for large acrylic appliances. This Kit contains 1 X 12g Excel Regular Adhesive paste in Jar Part A with fluoride , 1 X 12g Excel Regular Adhesive paste in jar Part B, 1 X 7g Bonding resin A , 1 X 7g Bonding resin B , 1 X 9g liquid Etchant and 1 X plastic Conditioner . Contains Fluoride.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
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Yes
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
Dentine bonding agent/set A material(s) primarily intended to be used as a bonding-promoting substance between dentine and a dental composite filling, restorative, or luting material. It includes a resin-based bonding agent and may also include a primer and/or etching solution (as a single formulation or as part of a set); composite resin is not included. It may also be used as an enamel bonding material. After application, this device cannot be reused.
Orthodontic bracket adhesive A bonding compound, e.g., polymethylmethacrylate (PMMA), used specifically to cement an orthodontic bracket to the surface of a tooth. After application, this device cannot be reused.
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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
August 15, 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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6307734009
paulgropi@aol.com
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