Evanesce™ Nano-Enhanced Universal Restorative Single Dose A3UX 323562

GUDID 00359883005092

Dental Composite Resin

DEN-MAT HOLDINGS, LLC

Dental composite resin

• Primary Device ID: 00359883005092
• NIH Device Record Key: d03bb3ce-2963-4fca-bff5-188da0261c60
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Evanesce™ Nano-Enhanced Universal Restorative Single Dose A3UX
• Version Model Number: 323562
• Catalog Number: 323562
• Company DUNS: 809857704
• Company Name: DEN-MAT HOLDINGS, LLC
• Device Count: 1
• DM Exempt: true
• 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: true
• 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: 0.25 Gram
• Weight: 0.25 Gram
• Weight: 0.25 Gram
• Weight: 0.25 Gram
• Weight: 0.25 Gram
• Weight: 0.25 Gram
• Weight: 0.25 Gram
• Weight: 0.25 Gram
• Weight: 0.25 Gram
• Weight: 0.25 Gram
• Weight: 0.25 Gram
• Weight: 0.25 Gram
• Weight: 0.25 Gram
• Weight: 0.25 Gram
• Weight: 0.25 Gram
• Weight: 0.25 Gram
• Weight: 0.25 Gram

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid heat direct sunlight radical starters Avoid contact with alkali metals hydrides strong oxidizing agents and radical initiators
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid heat direct sunlight radical starters Avoid contact with alkali metals hydrides strong oxidizing agents and radical initiators
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid heat direct sunlight radical starters Avoid contact with alkali metals hydrides strong oxidizing agents and radical initiators
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid heat direct sunlight radical starters Avoid contact with alkali metals hydrides strong oxidizing agents and radical initiators
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid heat direct sunlight radical starters Avoid contact with alkali metals hydrides strong oxidizing agents and radical initiators
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid heat direct sunlight radical starters Avoid contact with alkali metals hydrides strong oxidizing agents and radical initiators
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid heat direct sunlight radical starters Avoid contact with alkali metals hydrides strong oxidizing agents and radical initiators
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid heat direct sunlight radical starters Avoid contact with alkali metals hydrides strong oxidizing agents and radical initiators
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid heat direct sunlight radical starters Avoid contact with alkali metals hydrides strong oxidizing agents and radical initiators
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid heat direct sunlight radical starters Avoid contact with alkali metals hydrides strong oxidizing agents and radical initiators
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid heat direct sunlight radical starters Avoid contact with alkali metals hydrides strong oxidizing agents and radical initiators
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid heat direct sunlight radical starters Avoid contact with alkali metals hydrides strong oxidizing agents and radical initiators
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid heat direct sunlight radical starters Avoid contact with alkali metals hydrides strong oxidizing agents and radical initiators
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid heat direct sunlight radical starters Avoid contact with alkali metals hydrides strong oxidizing agents and radical initiators
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid heat direct sunlight radical starters Avoid contact with alkali metals hydrides strong oxidizing agents and radical initiators
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid heat direct sunlight radical starters Avoid contact with alkali metals hydrides strong oxidizing agents and radical initiators
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid heat direct sunlight radical starters Avoid contact with alkali metals hydrides strong oxidizing agents and radical initiators

Device Identifiers

Device Issuing Agency	Device ID
GS1	00359883005092 [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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