Affinity™ Inflex Reg Set w/o Tips 2-Pack 022400W

GUDID 00359883001902

VPS Impression Material

DEN-MAT HOLDINGS, LLC

Silicone dental impression material

• Primary Device ID: 00359883001902
• NIH Device Record Key: a287666a-eeb1-4a7f-ad0e-d88daafd3078
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Affinity™ Inflex Reg Set w/o Tips 2-Pack
• Version Model Number: 022400W
• Catalog Number: 022400W
• Company DUNS: 809857704
• Company Name: DEN-MAT HOLDINGS, LLC
• Device Count: 2
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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

• 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
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00359883001902 [Unit of Use]
GS1	00359883001919 [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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