EVANESCE 321523

GUDID 03598833215236

EVANESCE BULK FILL A2 SY 1X6G

DEN-MAT HOLDINGS, LLC

Dental composite resin

• Primary Device ID: 03598833215236
• NIH Device Record Key: 0722c176-eff4-49bd-81bb-690e30ebc4ee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EVANESCE
• Version Model Number: 321523
• Catalog Number: 321523
• 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: 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Direct Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Excessive Heat or Light
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Direct Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Excessive Heat or Light
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Direct Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Excessive Heat or Light
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Direct Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Excessive Heat or Light
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Direct Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Excessive Heat or Light
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Direct Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Avoid Excessive Heat or Light

Device Identifiers

Device Issuing Agency	Device ID
GS1	03598833215236 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242097

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: 2024-12-23
• Device Publish Date: 2024-12-13

On-Brand Devices [EVANESCE]

• 03598833215250: EVANESCE BULK CURE A3 SY 1X6G
• 03598833215236: EVANESCE BULK FILL A2 SY 1X6G
• 00359883973216: EVANESCE BULK CURE A2 SY 1x3g