DEVICE: ALPHA-DENT® Self Cure Bracket Bonding Resin (D73521001020010)

Device Identifier (DI) Information

ALPHA-DENT® Self Cure Bracket Bonding Resin
210.0201.001
In Commercial Distribution
210.0201.001
DENTAL TECHNOLOGIES, INC.
D73521001020010
HIBCC

1
148312838 *Terms of Use
ALPHA-DENT® Self Cure Bracket Bonding Resin is a self cure two paste system formulated to bond to metal, ceramic and plastic brackets. The unique filler combination used in the pastes produces a superior bond when used with Self Cure Bracket Bonding Resin and minimized bond failures. Kit Contains: 1 x 7ml Bracket Bonding Catalyst
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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
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.
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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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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K930614 000
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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
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 Record Status

6a49b2a7-7c2e-4410-8cd9-2d6451ba93cb
July 06, 2018
3
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
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Yes
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Customer Contact

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847-677-5500
info@dentaltech.com
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