BondLink 031148100

GUDID D8130311481000

BONDLINK KIT

DEN-MAT HOLDINGS, LLC

Dentine adhesive Dentine adhesive

• Primary Device ID: D8130311481000
• NIH Device Record Key: 440dfc8f-be51-43a0-adfd-2616733fb421
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BondLink
• Version Model Number: 031148100
• Catalog Number: 031148100
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 75 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D8130311481000 [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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

Devices Manufactured by DEN-MAT HOLDINGS, LLC

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• D8130561006970 - VAKT: 2023-04-26 VAKT ALIGNER UPR & LWR
• D8130303761050 - GBLOCK: 2023-03-14 GBLOCK DESENSITIZER 5ml
• D8130303761100 - GBLOCK: 2023-03-14 GBLOCK DESENSITIZER 10ml
• D8130562005300 - VAKT PRIVATE LABEL: 2023-03-14 VAKT ALIGNER UPPER
• D8130562005350 - ORTHOCLEAR - PL VAKT: 2023-03-14 VAKT ALIGNER LOWER
• D8130562005500 - VAKT PRIVATE LABEL: 2023-03-14 VAKT RETAINER UPPER
• D8130562005550 - VAKT PRIVATE LABEL: 2023-03-14 VAKT RETAINER LOWER