DEVICE: ALPHA-DENT® Self Cure Bonding Adhesive (D73520001020010)

Device Identifier (DI) Information

ALPHA-DENT® Self Cure Bonding Adhesive
200.0102.001
In Commercial Distribution
200.0102.001
DENTAL TECHNOLOGIES, INC.
D73520001020010
HIBCC

1
148312838 *Terms of Use
ALPHA-DENT® Self Cure Bonding Adhesive is designed for bonding composite resin materials to dentin and enamel. The ideal viscosity allows the material to penetrate into microtubules to enhance mechanical adhesion. Kit Contains: 3ml Base Adhesive, 3ml Base Bonding Resin
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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
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
KLE Agent, Tooth Bonding, Resin
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K984503 000
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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 Record Status

2cc80c77-ceb7-4be6-b955-d1cc755dcc08
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
No
Yes
No
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Customer Contact

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847-677-5500
info@dentaltech.com
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