DEVICE: ALPHA-DENT® Paste & Paste Orthodontic Adhesive (D73530201010010)

Device Identifier (DI) Information

ALPHA-DENT® Paste & Paste Orthodontic Adhesive
302.0101.001
In Commercial Distribution
302.0101.001
DENTAL TECHNOLOGIES, INC.
D73530201010010
HIBCC

1
148312838 *Terms of Use
ALPHA-DENT® Paste & Paste Orthodontic Adhesive is a self cure two paste system formulated to bond to metal, ceramic and plastic brackets. The unique filler combination used in the pastes produces a superior bond when used with Self Cure Bracket Bonding Resin and minimizes bonding failures. Kit Contains: 1 x 14g Base Paste
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
DYH Adhesive, Bracket And Tooth Conditioner, Resin
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K930614 000
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 20 and 25 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

5b406857-868d-436e-a4c1-49d6094806ec
July 06, 2018
3
September 23, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
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

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
847-677-5500
info@dentaltech.com
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