Affnity™ Inflex FS Affinity Cartridge 012405

GUDID 00359883001506

VPS Impression Tray Material

DEN-MAT HOLDINGS, LLC

Silicone dental impression material

• Primary Device ID: 00359883001506
• NIH Device Record Key: f17e118f-58d8-4828-b884-5cd95dfac684
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Affnity™ Inflex FS Affinity Cartridge
• Version Model Number: 012405
• Catalog Number: 012405
• 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: false
• 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
• Phone: +1(800)433-6628
• Email: info@denmat.com
• Phone: +1(800)433-6628
• Email: info@denmat.com

Device Dimensions

• Total Volume: 50 Milliliter
• Total Volume: 50 Milliliter
• Total Volume: 50 Milliliter
• Total Volume: 50 Milliliter
• Total Volume: 50 Milliliter
• Total Volume: 50 Milliliter
• Total Volume: 50 Milliliter
• Total Volume: 50 Milliliter
• Total Volume: 50 Milliliter
• Total Volume: 50 Milliliter
• Total Volume: 50 Milliliter
• Total Volume: 50 Milliliter
• Total Volume: 50 Milliliter
• Total Volume: 50 Milliliter
• Total Volume: 50 Milliliter
• Total Volume: 50 Milliliter
• Total Volume: 50 Milliliter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Min Relative Humidity. Ensure Adequate Ventilation
• Storage Environment Temperature: Between 18 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 65 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Min Relative Humidity. Ensure Adequate Ventilation
• Storage Environment Temperature: Between 18 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 65 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Min Relative Humidity. Ensure Adequate Ventilation
• Storage Environment Temperature: Between 18 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 65 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Min Relative Humidity. Ensure Adequate Ventilation
• Storage Environment Temperature: Between 18 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 65 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Min Relative Humidity. Ensure Adequate Ventilation
• Storage Environment Temperature: Between 18 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 65 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Min Relative Humidity. Ensure Adequate Ventilation
• Storage Environment Temperature: Between 18 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 65 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Min Relative Humidity. Ensure Adequate Ventilation
• Storage Environment Temperature: Between 18 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 65 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Min Relative Humidity. Ensure Adequate Ventilation
• Storage Environment Temperature: Between 18 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 65 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Min Relative Humidity. Ensure Adequate Ventilation
• Storage Environment Temperature: Between 18 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 65 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Min Relative Humidity. Ensure Adequate Ventilation
• Storage Environment Temperature: Between 18 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 65 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Min Relative Humidity. Ensure Adequate Ventilation
• Storage Environment Temperature: Between 18 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 65 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Min Relative Humidity. Ensure Adequate Ventilation
• Storage Environment Temperature: Between 18 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 65 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Min Relative Humidity. Ensure Adequate Ventilation
• Storage Environment Temperature: Between 18 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 65 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Min Relative Humidity. Ensure Adequate Ventilation
• Storage Environment Temperature: Between 18 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 65 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Min Relative Humidity. Ensure Adequate Ventilation
• Storage Environment Temperature: Between 18 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 65 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Min Relative Humidity. Ensure Adequate Ventilation
• Storage Environment Temperature: Between 18 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 65 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Min Relative Humidity. Ensure Adequate Ventilation
• Storage Environment Temperature: Between 18 Degrees Celsius and 24 Degrees Celsius
• Storage Environment Temperature: Between 65 Degrees Fahrenheit and 75 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00359883001506 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K053014

FDA Product Code

• ELW: MATERIAL, IMPRESSION

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-03-20
• Device Publish Date: 2025-03-12

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