Prime&Bond active 60667340

GUDID D010606673401

Prime&Bond active® universal adhesive is a combined Etch&Rinse (Total-Etch), Self-Etch and Selective-Enamel-Etch adhesive. It offers a simple adhesive application technique for both direct and indirect indications and bonds to enamel, dentin, composites, zirconia and metals.

Dentsply De Trey GmbH

Dentine bonding agent/set

• Primary Device ID: D010606673401
• NIH Device Record Key: 662a4634-ee2b-4cc6-9855-e505f73e329a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Prime&Bond active
• Version Model Number: 60667340
• Catalog Number: 60667340
• Company DUNS: 315471722
• Company Name: Dentsply De Trey GmbH
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Use the product at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Keep the product out of direct sunlight and store in a well-ventilated place.
• Storage Environment Temperature: Between 2 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Use the product at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Keep the product out of direct sunlight and store in a well-ventilated place.
• Storage Environment Temperature: Between 2 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Use the product at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Keep the product out of direct sunlight and store in a well-ventilated place.
• Storage Environment Temperature: Between 2 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Use the product at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Keep the product out of direct sunlight and store in a well-ventilated place.
• Storage Environment Temperature: Between 2 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Use the product at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Keep the product out of direct sunlight and store in a well-ventilated place.
• Storage Environment Temperature: Between 2 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Use the product at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Keep the product out of direct sunlight and store in a well-ventilated place.
• Storage Environment Temperature: Between 2 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Use the product at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Keep the product out of direct sunlight and store in a well-ventilated place.
• Storage Environment Temperature: Between 2 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Use the product at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Keep the product out of direct sunlight and store in a well-ventilated place.
• Storage Environment Temperature: Between 2 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Use the product at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Keep the product out of direct sunlight and store in a well-ventilated place.
• Storage Environment Temperature: Between 2 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Use the product at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Keep the product out of direct sunlight and store in a well-ventilated place.
• Storage Environment Temperature: Between 2 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Use the product at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Keep the product out of direct sunlight and store in a well-ventilated place.
• Storage Environment Temperature: Between 2 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Use the product at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Keep the product out of direct sunlight and store in a well-ventilated place.
• Storage Environment Temperature: Between 2 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Use the product at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Keep the product out of direct sunlight and store in a well-ventilated place.
• Storage Environment Temperature: Between 2 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Use the product at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Keep the product out of direct sunlight and store in a well-ventilated place.
• Storage Environment Temperature: Between 2 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Use the product at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Keep the product out of direct sunlight and store in a well-ventilated place.
• Storage Environment Temperature: Between 2 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Use the product at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Keep the product out of direct sunlight and store in a well-ventilated place.
• Storage Environment Temperature: Between 2 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Use the product at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Keep the product out of direct sunlight and store in a well-ventilated place.
• Storage Environment Temperature: Between 2 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Use the product at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Keep the product out of direct sunlight and store in a well-ventilated place.
• Storage Environment Temperature: Between 2 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Use the product at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Keep the product out of direct sunlight and store in a well-ventilated place.
• Storage Environment Temperature: Between 2 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Use the product at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Keep the product out of direct sunlight and store in a well-ventilated place.
• Storage Environment Temperature: Between 2 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Use the product at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Keep the product out of direct sunlight and store in a well-ventilated place.
• Storage Environment Temperature: Between 2 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Use the product at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Keep the product out of direct sunlight and store in a well-ventilated place.
• Storage Environment Temperature: Between 2 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Use the product at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Keep the product out of direct sunlight and store in a well-ventilated place.
• Storage Environment Temperature: Between 2 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Use the product at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Keep the product out of direct sunlight and store in a well-ventilated place.
• Storage Environment Temperature: Between 2 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Use the product at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Keep the product out of direct sunlight and store in a well-ventilated place.
• Storage Environment Temperature: Between 2 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Use the product at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Keep the product out of direct sunlight and store in a well-ventilated place.
• Storage Environment Temperature: Between 2 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Use the product at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Keep the product out of direct sunlight and store in a well-ventilated place.
• Storage Environment Temperature: Between 2 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Use the product at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Keep the product out of direct sunlight and store in a well-ventilated place.
• Storage Environment Temperature: Between 2 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Use the product at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Keep the product out of direct sunlight and store in a well-ventilated place.
• Storage Environment Temperature: Between 2 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Use the product at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Keep the product out of direct sunlight and store in a well-ventilated place.
• Storage Environment Temperature: Between 2 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Use the product at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Keep the product out of direct sunlight and store in a well-ventilated place.
• Storage Environment Temperature: Between 2 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Use the product at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Keep the product out of direct sunlight and store in a well-ventilated place.
• Storage Environment Temperature: Between 2 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Use the product at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Keep the product out of direct sunlight and store in a well-ventilated place.
• Storage Environment Temperature: Between 2 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Use the product at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Keep the product out of direct sunlight and store in a well-ventilated place.
• Storage Environment Temperature: Between 2 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Use the product at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Keep the product out of direct sunlight and store in a well-ventilated place.
• Storage Environment Temperature: Between 2 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Use the product at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Keep the product out of direct sunlight and store in a well-ventilated place.
• Storage Environment Temperature: Between 2 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Use the product at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Keep the product out of direct sunlight and store in a well-ventilated place.
• Storage Environment Temperature: Between 2 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Use the product at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Keep the product out of direct sunlight and store in a well-ventilated place.
• Storage Environment Temperature: Between 2 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Use the product at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Keep the product out of direct sunlight and store in a well-ventilated place.
• Storage Environment Temperature: Between 2 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Use the product at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Keep the product out of direct sunlight and store in a well-ventilated place.
• Storage Environment Temperature: Between 2 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Use the product at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Keep the product out of direct sunlight and store in a well-ventilated place.
• Storage Environment Temperature: Between 2 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Use the product at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Keep the product out of direct sunlight and store in a well-ventilated place.
• Storage Environment Temperature: Between 2 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Use the product at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Keep the product out of direct sunlight and store in a well-ventilated place.

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D010606673401 [Primary]

FDA Product Code

• KLE: AGENT, TOOTH BONDING, RESIN

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-12-11
• Device Publish Date: 2023-12-01

On-Brand Devices [Prime&Bond active]

• D010606673541: Prime&Bond active® universal adhesive is a combined Etch&Rinse (Total-Etch), Self-Etch and Sele
• D010606673531: Prime&Bond active® universal adhesive is a combined Etch&Rinse (Total-Etch), Self-Etch and Sele
• D010606673481: Prime&Bond active® universal adhesive is a combined Etch&Rinse (Total-Etch), Self-Etch and Sele
• D010606673471: Prime&Bond active® universal adhesive is a combined Etch&Rinse (Total-Etch), Self-Etch and Sele
• D010606673451: Prime&Bond active® universal adhesive is a combined Etch&Rinse (Total-Etch), Self-Etch and Sele
• D010606673441: Prime&Bond active® universal adhesive is a combined Etch&Rinse (Total-Etch), Self-Etch and Sele
• D010606673431: Prime&Bond active® universal adhesive is a combined Etch&Rinse (Total-Etch), Self-Etch and Sele
• D010606673421: Prime&Bond active® universal adhesive is a combined Etch&Rinse (Total-Etch), Self-Etch and Sele
• D010606673401: Prime&Bond active® universal adhesive is a combined Etch&Rinse (Total-Etch), Self-Etch and Sele
• D010606673411: Prime&Bond active Standard Refill universal adhesive is a combined Etch&Rinse (Total Etch), Self