MAGNA 4.0 CR1079ABC

GUDID D813CR1079ABC0

AVID BLUE CURE CURING LIGHT

DEN-MAT HOLDINGS, LLC

Dental/surgical polymerization lamp

• Primary Device ID: D813CR1079ABC0
• NIH Device Record Key: ff52566f-cacd-499a-9b8e-ce6104422637
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MAGNA 4.0
• Version Model Number: CR1079ABC
• Catalog Number: CR1079ABC
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• 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: 1-800-4336628
• Email: info@denmat.com
• Phone: 1-800-4336628
• Email: info@denmat.com

Operating and Storage Conditions

• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D813CR1079ABC0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K073518

FDA Product Code

• EBZ: Activator, Ultraviolet, For Polymerization

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-09-28

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• 03598833235296 - EVANESCE: 2025-01-07 EVANESCE INJECTABLE BL1U SYR
• 03598833235302 - EVANESCE: 2025-01-07 EVANESCE INJECTABLE A3U SYR
• 00359883973216 - EVANESCE: 2024-12-23 EVANESCE BULK CURE A2 SY 1x3g
• 03598833215236 - EVANESCE: 2024-12-23 EVANESCE BULK FILL A2 SY 1X6G