DEVICE: Alpha-Bond® Activator (D73521102010020)
Device Identifier (DI) Information
Alpha-Bond® Activator
211.0201.002
In Commercial Distribution
211.0201.002
DENTAL TECHNOLOGIES, INC.
211.0201.002
In Commercial Distribution
211.0201.002
DENTAL TECHNOLOGIES, INC.
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
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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34782 | 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 may also be used as an enamel bonding material. It includes a resin-based bonding agent and may also include a primer, etching solution or curing activator, within the same formulation, or as part of a set. It is not a primer, etching solution and/or activator sold in the absence of a bonding agent; composite resin is not included. After application, this device cannot be reused.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KLE | Agent, Tooth Bonding, Resin |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K984503 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 2 and 27 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
6263655b-3171-42d9-801d-85e238a52b5f
February 16, 2024
4
September 23, 2016
February 16, 2024
4
September 23, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
847-677-5500
info@dentaltech.com
info@dentaltech.com