DEVICE: Alpha-Bond® Activator (D73521102010020)

Device Identifier (DI) Information

Alpha-Bond® Activator
211.0201.002
In Commercial Distribution
211.0201.002
DENTAL TECHNOLOGIES, INC.
D73521102010020
HIBCC

1
148312838 *Terms of Use
Alpha-Bond® Activator is the dual cure activator used in combination with Alpha-Bond® a 5th generation single component acetone based formulated to bond to multiple substrates for both direct and indirect bonding procedures. It contains a hydrophilic monomer that allows penetration into the tubules, intertubules and peritubuler dentin. For a single step light cure adhesive, use the bottle marked adhesive. By combining the dual cure activator with the adhesive, you can confidently bond to self cure composites and areas inaccessible to light. Kit Contains: 1 x 3ml Bottle
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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 [?]
Premarket Submission Number Not Available/Not Released
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Sterilization

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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

6263655b-3171-42d9-801d-85e238a52b5f
March 29, 2018
2
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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