Evanesce™ Nano-Enhanced Universal Restorative Enamel FX Clear 321513

GUDID 00359883004637

Dental Composite Resin

DEN-MAT HOLDINGS, LLC

Dental composite resin

• Primary Device ID: 00359883004637
• NIH Device Record Key: 481c3920-aef9-4325-a126-b3f13d65055e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Evanesce™ Nano-Enhanced Universal Restorative Enamel FX Clear
• Version Model Number: 321513
• Catalog Number: 321513
• 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: 3 Gram
• Weight: 3 Gram
• Weight: 3 Gram
• Weight: 3 Gram
• Weight: 3 Gram
• Weight: 3 Gram
• Weight: 3 Gram
• Weight: 3 Gram
• Weight: 3 Gram
• Weight: 3 Gram
• Weight: 3 Gram
• Weight: 3 Gram
• Weight: 3 Gram
• Weight: 3 Gram
• Weight: 3 Gram
• Weight: 3 Gram
• Weight: 3 Gram

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00359883004637 [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

Devices Manufactured by DEN-MAT HOLDINGS, LLC

• 00359883005665 - Tissue Goo™ Hemostatic Gel 4-Pack: 2025-03-26 Gingival Retraction Solution
• 00359883005672 - Tissue Goo™ Hemostatic Gel Big Shot Syringe Kit: 2025-03-26 Gingival Retraction Solution
• 00359883002046 - Affinity™ Heavy Body RS 120ml 2-Pack: 2025-03-24 VPS Impression Material
• 00359883006273 - Final Shine Cotton Polishing Wheel 50-Pack: 2025-03-21 Wheel, Polishing Agent
• 00359883006501 - Clinician's Choice® G5 Sample Pack: 2025-03-21 Dental coating, tooth-desensitizing, professional
• 00359883000608 - PowerMix™ Automatic Impression Material Dispenser: 2025-03-20 Two-component dental material applicator, electric
• 00359883000615 - PowerMix™ Dynamic Mixing Tips: 2025-03-20 Dental material mixing nozzle, non-sterile
• 00359883000882 - Dual-Force™ Sectional Matrix System Pre-Molar Rings Orange: 2025-03-20 Device to engage the matrices and separate teeth