DEVICE: Tenure® (D8131146B0)

Device Identifier (DI) Information

Tenure®
1146B
In Commercial Distribution
1146B
DEN-MAT HOLDINGS, LLC
D8131146B0
HIBCC

1
809857704 *Terms of Use
TENURE B ADHESIVE 6mL
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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
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 includes a resin-based bonding agent and may also include a primer and/or etching solution (as a single formulation or as part of a set); composite resin is not included. It may also be used as an enamel bonding material. After application, this device cannot be reused.
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FDA Product Code

[?]
Product Code Product Code Name
EBF Material, Tooth Shade, Resin
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

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

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Storage and Handling
Storage Environment Temperature: between 36 and 77 Degrees Fahrenheit
Handling Environment Temperature: between 36 and 77 Degrees Fahrenheit
Special Storage Condition, Specify: Do not freeze
Special Storage Condition, Specify: Do not expose to source of ignition or open flame
Special Storage Condition, Specify: Do not expose to direct sunlight
Special Storage Condition, Specify: Recommended temperature when used is 70-75
Special Storage Condition, Specify: Cold storage recommended in tropical climates
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

03d4fc8b-eec2-457a-b20b-28890b959c42
May 03, 2018
3
September 24, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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

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

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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

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