DEVICE: Complete Bonding Kit (D7796540053)

Device Identifier (DI) Information

Complete Bonding Kit
654005
In Commercial Distribution
654005
COSMEDENT, INC.
D7796540053
HIBCC

1
113911689 *Terms of Use
Complete Bonding Kit includes 1 bottle of Primer/Unfilled Resin, 1 bottle of Dual-Cure Catalyst, 1 bottle of Unfilled Resin, one #1 brush/straight; and one #1 brush/bent in Tray.
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Device Characteristics

Labeling does not contain MRI Safety Information
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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
Dental composite adhesive kit A collection of devices intended to be used to bond attachments such as hooks or buttons to the teeth and/or to an orthodontic aligner during dental or orthodontic teeth adjustment. The adhesives are typically based on light-cured bonding composites (e.g., 400-500nm range). The contents of this kit may include etchant, bonding resin, bonding paste, spatula, brushes, and a paper pad. This is a reusable device.
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FDA Product Code

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Product Code Product Code Name
No Product Codes
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FDA Premarket Submission

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Premarket Submission Number Not Available/Not Released
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Sterilization

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Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
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Device Record Status

096775dc-2463-42f1-8e8f-8dd7cb1a71dc
March 29, 2018
2
September 22, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Secondary DI

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Unit of Use DI

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Direct Marking (DM)

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None
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Production Identifier(s) in UDI

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Customer Contact

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No Customer Contact currently defined
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