Evanesce™ Nano-Enhanced Universal Restorative Enamel FX Incisal 321515

GUDID 00359883004651

Dental Composite Resin

DEN-MAT HOLDINGS, LLC

Dental composite resin

• Primary Device ID: 00359883004651
• NIH Device Record Key: 88ffc0b8-3ab0-4e27-a1d3-8adf43d9ffca
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Evanesce™ Nano-Enhanced Universal Restorative Enamel FX Incisal
• Version Model Number: 321515
• Catalog Number: 321515
• 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: 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

• Weight: 4 Gram
• Weight: 4 Gram
• Weight: 4 Gram
• Weight: 4 Gram
• Weight: 4 Gram
• Weight: 4 Gram
• Weight: 4 Gram
• Weight: 4 Gram
• Weight: 4 Gram
• Weight: 4 Gram
• Weight: 4 Gram
• Weight: 4 Gram
• Weight: 4 Gram
• Weight: 4 Gram
• Weight: 4 Gram
• Weight: 4 Gram
• Weight: 4 Gram

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 78 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from direct sunlight
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 78 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from direct sunlight
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 78 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from direct sunlight
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 78 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from direct sunlight
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 78 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from direct sunlight
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 78 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from direct sunlight
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 78 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from direct sunlight
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 78 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from direct sunlight
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 78 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from direct sunlight
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 78 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from direct sunlight
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 78 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from direct sunlight
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 78 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from direct sunlight
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 78 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from direct sunlight
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 78 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from direct sunlight
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 78 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from direct sunlight
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 78 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from direct sunlight
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 78 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from direct sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	00359883004651 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K984484

FDA Product Code

• EBF: Material, tooth shade, resin

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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