DEVICE: ALPHA-DENT® Light Cure Bracket Adhesive (D73530300050010)

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Device Identifier (DI) Information

ALPHA-DENT® Light Cure Bracket Adhesive
303.0005.001
303.0005.001
DENTAL TECHNOLOGIES, INC.
D73530300050010
HIBCC
1
ALPHA-DENT® Light Cure Bracket Adhesive is a Paste-Adhesive system formulated to bond to metal, ceramic, and plastic brackets. The unique filler combination used in the paste produces an ideal bond and a smooth tacky consistency minimizing bracket floatation. By using light cure adhesive technology we have eliminated working time contraints. Kit Contains: 40 x .35g Adhesive, 7ml LC Bracket Bonding Resin, 2 x 4g Etchant Gel Syringes, Dispensing Tips, Brushes, Dispensing Pad
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
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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
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
Storage Environment Temperature: between 2 and 27 Degrees Celsius
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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
September 23, 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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847-677-5500
info@dentaltech.com
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