DEVICE: ALPHA-DENT® Light Cure Bracket Adhesive (D73530300050010)
Device Identifier (DI) Information
ALPHA-DENT® Light Cure Bracket Adhesive
303.0005.001
In Commercial Distribution
303.0005.001
DENTAL TECHNOLOGIES, INC.
303.0005.001
In Commercial Distribution
303.0005.001
DENTAL TECHNOLOGIES, INC.
ALPHA-DENT® Light Cure Bracket Adhesive is a Paste-Adhesive system formulated to bond to metal, ceramic, and plastic brackets. The unique filler combination used in the paste produces an ideal bond and a smooth tacky consistency minimizing bracket floatation. By using light cure adhesive technology we have eliminated working time contraints. Kit Contains: 40 x .35g Adhesive, 7ml LC Bracket Bonding Resin, 2 x 4g Etchant Gel Syringes, Dispensing Tips, Brushes, Dispensing Pad
Device Characteristics
Labeling does not contain MRI Safety Information | |
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Yes | |
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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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31750 | Orthodontic bracket adhesive |
A bonding compound, e.g., polymethylmethacrylate (PMMA), used specifically to cement an orthodontic bracket to the surface of a tooth. After application, this device cannot be reused.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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DYH | Adhesive, Bracket And Tooth Conditioner, Resin |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K935625 | 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
394ee4d7-d3bf-434a-af5f-a77f4cbc592a
July 06, 2018
3
September 23, 2016
July 06, 2018
3
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