DEVICE: Tenure® (D813032245101B0)

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Device Record History
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Device Identifier (DI) Information
Tenure®
032245101B
In Commercial Distribution
032245101B
DEN-MAT HOLDINGS, LLC
D813032245101B0
HIBCC

1
809857704 *Terms of Use
TENURE S BND ENH 6mL R:1
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Device Characteristics
Labeling does not contain MRI Safety Information
No
Yes
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. 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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
KLE Agent, Tooth Bonding, Resin
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K801216 000
No CLOSE

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

[?]
Storage and Handling
Special Storage Condition, Specify: Recommended temperature when used is 70° - 75° F (21° - 24° C)
Special Storage Condition, Specify: Do not expose to direct sunlight
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 or refrigerate
Special Storage Condition, Specify: Do not expose to temperatures exceeding 80° F (27° C)
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
75f3264c-6d7b-4a1a-b363-0d2e1fdef2d6
February 16, 2024
5
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
Yes
No
No CLOSE

Customer Contact

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