EVANESCE 973210

GUDID 00359883973216

EVANESCE BULK CURE A2 SY 1x3g

DEN-MAT HOLDINGS, LLC

Dental composite resin

• Primary Device ID: 00359883973216
• NIH Device Record Key: 73940756-a855-4804-9d68-8c69f8d32bd5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EVANESCE
• Version Model Number: 973210
• Catalog Number: 973210
• 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: true
• Expiration Date: false
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze
• Special Storage Condition, Specify: Between 0 and 0 *Aviod 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 *Aviod 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 *Aviod 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 *Aviod 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 *Aviod 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 *Aviod 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 *Aviod 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 *Aviod 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 *Aviod 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 *Aviod 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00359883973216 [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

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• 00359883973216: EVANESCE BULK CURE A2 SY 1x3g
• 03598833235302: EVANESCE INJECTABLE A3U SYR
• 03598833235296: EVANESCE INJECTABLE BL1U SYR
• 03598833235289: EVANESCE INJECTABLE B1U SYR
• 03598833235272: EVANESCE INJECTABLE A2U SYR
• 03598833235265: EVANESCE EVANESCE INJECTABLE
• 03598833235166: EVANESCE INJECTABLE ENW SYR
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