DEVICE: ALPHA-DENT® One Step Primer (D73520901010010)
Device Identifier (DI) Information
ALPHA-DENT® One Step Primer
209.0101.001
In Commercial Distribution
209.0101.001
DENTAL TECHNOLOGIES, INC.
209.0101.001
In Commercial Distribution
209.0101.001
DENTAL TECHNOLOGIES, INC.
ALPHA-DENT® One Step Primer is part of the Paste-Primer system formulated to bond to metal, ceramic and plastic brackets. Kit Contains: 1 x 12ml Primer
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No | |
Yes | |
No | |
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No |
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? |
---|---|---|---|---|
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 |
---|---|
DYH | Adhesive, Bracket And Tooth Conditioner, Resin |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K921044 | 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
b09d529c-5846-4f52-b6a4-734fe503396e
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