DEVICE: Dry-Bond (D81375000)

Device Identifier (DI) Information

Dry-Bond
7500
In Commercial Distribution
7500
DEN-MAT HOLDINGS, LLC
D81375000
HIBCC

1
809857704 *Terms of Use
DRY-BOND 240mL
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Device Characteristics

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

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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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FDA Product Code

[?]
Product Code Product Code Name
KZP Solution, Cement Disolving
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K771974 000
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Sterilization

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

[?]
Storage and Handling
Handling Environment Temperature: between 36 and 77 Degrees Fahrenheit
Storage Environment Temperature: between 36 and 77 Degrees Fahrenheit
Special Storage Condition, Specify: Do not expose to source of ignition or open flame
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Clinically Relevant Size

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

e6396b4b-4eb1-4e63-abc1-783a9276291f
July 06, 2018
3
September 24, 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
No
Yes
No CLOSE

Customer Contact

[?]
1-800-433-6628
info@denmat.com
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