Tenure® 030412902

GUDID D8130304129020

TENURE UBOND SOL B 6mL RFL KIT

DEN-MAT HOLDINGS, LLC

Dentine bonding agent/set

• Primary Device ID: D8130304129020
• NIH Device Record Key: 5dd8f255-4e41-48d9-9303-31622232bb2b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tenure®
• Version Model Number: 030412902
• Catalog Number: 030412902
• Company DUNS: 809857704
• Company Name: DEN-MAT HOLDINGS, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-433-6628
• Email: info@denmat.com
• Phone: 1-800-433-6628
• Email: info@denmat.com
• Phone: 1-800-433-6628
• Email: info@denmat.com
• Phone: 1-800-433-6628
• Email: info@denmat.com
• Phone: 1-800-433-6628
• Email: info@denmat.com
• Phone: 1-800-433-6628
• Email: info@denmat.com
• Phone: 1-800-433-6628
• Email: info@denmat.com
• Phone: 1-800-433-6628
• Email: info@denmat.com
• Phone: 1-800-433-6628
• Email: info@denmat.com
• Phone: 1-800-433-6628
• Email: info@denmat.com
• Phone: 1-800-433-6628
• Email: info@denmat.com
• Phone: 1-800-433-6628
• Email: info@denmat.com
• Phone: 1-800-433-6628
• Email: info@denmat.com
• Phone: 1-800-433-6628
• Email: info@denmat.com
• Phone: 1-800-433-6628
• Email: info@denmat.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Recommended temperature when used is 70° - 75° F (21° - 24° C).
• Special Storage Condition, Specify: Between 0 and 0 *" Do not expose to direct sunlight.."
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to temperatures exceeding 80° F (27° C).
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze or refrigerate
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Recommended temperature when used is 70° - 75° F (21° - 24° C).
• Special Storage Condition, Specify: Between 0 and 0 *" Do not expose to direct sunlight.."
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to temperatures exceeding 80° F (27° C).
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze or refrigerate
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Recommended temperature when used is 70° - 75° F (21° - 24° C).
• Special Storage Condition, Specify: Between 0 and 0 *" Do not expose to direct sunlight.."
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to temperatures exceeding 80° F (27° C).
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze or refrigerate
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Recommended temperature when used is 70° - 75° F (21° - 24° C).
• Special Storage Condition, Specify: Between 0 and 0 *" Do not expose to direct sunlight.."
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to temperatures exceeding 80° F (27° C).
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze or refrigerate
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Recommended temperature when used is 70° - 75° F (21° - 24° C).
• Special Storage Condition, Specify: Between 0 and 0 *" Do not expose to direct sunlight.."
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to temperatures exceeding 80° F (27° C).
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze or refrigerate
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Recommended temperature when used is 70° - 75° F (21° - 24° C).
• Special Storage Condition, Specify: Between 0 and 0 *" Do not expose to direct sunlight.."
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to temperatures exceeding 80° F (27° C).
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze or refrigerate
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Recommended temperature when used is 70° - 75° F (21° - 24° C).
• Special Storage Condition, Specify: Between 0 and 0 *" Do not expose to direct sunlight.."
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to temperatures exceeding 80° F (27° C).
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze or refrigerate
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Recommended temperature when used is 70° - 75° F (21° - 24° C).
• Special Storage Condition, Specify: Between 0 and 0 *" Do not expose to direct sunlight.."
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to temperatures exceeding 80° F (27° C).
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze or refrigerate
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Recommended temperature when used is 70° - 75° F (21° - 24° C).
• Special Storage Condition, Specify: Between 0 and 0 *" Do not expose to direct sunlight.."
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to temperatures exceeding 80° F (27° C).
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze or refrigerate
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Recommended temperature when used is 70° - 75° F (21° - 24° C).
• Special Storage Condition, Specify: Between 0 and 0 *" Do not expose to direct sunlight.."
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to temperatures exceeding 80° F (27° C).
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze or refrigerate
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Recommended temperature when used is 70° - 75° F (21° - 24° C).
• Special Storage Condition, Specify: Between 0 and 0 *" Do not expose to direct sunlight.."
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to temperatures exceeding 80° F (27° C).
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze or refrigerate
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Recommended temperature when used is 70° - 75° F (21° - 24° C).
• Special Storage Condition, Specify: Between 0 and 0 *" Do not expose to direct sunlight.."
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to temperatures exceeding 80° F (27° C).
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze or refrigerate
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Recommended temperature when used is 70° - 75° F (21° - 24° C).
• Special Storage Condition, Specify: Between 0 and 0 *" Do not expose to direct sunlight.."
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to temperatures exceeding 80° F (27° C).
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze or refrigerate
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Recommended temperature when used is 70° - 75° F (21° - 24° C).
• Special Storage Condition, Specify: Between 0 and 0 *" Do not expose to direct sunlight.."
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to temperatures exceeding 80° F (27° C).
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze or refrigerate
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D8130304129020 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K801216

FDA Product Code

• KLE: Agent, Tooth Bonding, Resin

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

On-Brand Devices [Tenure®]

• D813TEN40000: TENURE 4G BONDING SYSTEM
• D8131146B0: TENURE B ADHESIVE 6mL
• D8131145B0: TENURE A ADHESIVE 6mL
• D813032245101B0: TENURE S BND ENH 6mL R:1
• D8130311460000: TENURE MPB SYSTEM R:1
• D8130311457000: TENURE Q W/FLUORIDE KIT
• D8130311453000: TENURE Q W/FLUOR REFILL KIT
• D813031145110B0: TENURE S FILLED BND ENH 3mL
• D8130311451000: TENURE S VALUE KIT
• D8130304510100: GLOSS 'N' SEAL BAGGED
• D8130304129020: TENURE UBOND SOL B 6mL RFL KIT
• D8130304129010: TENURE UBOND SOL A 6mL RFL KIT
• D8130304119000: TENURE UNI BOND KIT
• D8130301146100: TENURE MPB B ADH 6mL RFL KIT
• D8130301145100: TENURE MPB A ADH 6mL RFL KIT