Flashlite® CR1080R

GUDID D813CR1080R0

LT FLASHLITE 2.0 REPLACEMENT

DEN-MAT HOLDINGS, LLC

Dental/surgical polymerization lamp Dental/surgical polymerization lamp

• Primary Device ID: D813CR1080R0
• NIH Device Record Key: e4077fb7-f4db-48dd-ad63-b66083b2ecc7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Flashlite®
• Version Model Number: CR1080R
• Catalog Number: CR1080R
• 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: false
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage 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
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D813CR1080R0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K023748

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: 2016-09-24

On-Brand Devices [Flashlite®]

• D813CR10830: FL MAGNA 4.0 CHARGER BASE
• D813CR1080R0: LT FLASHLITE 2.0 REPLACEMENT
• D813CR10800: LT FLASHLITE 2.0
• D813CR1079R0: LT FLASHLITE MAGNA 4.0 RPLCMNT
• D813CR1079P0: LT FLASHLITE MAGNA 4.0 PINK
• D813CR10790: LT FLASHLITE MAGNA 4.0
• D813CR10630: FL 2.0 CHARGER BASE
• D813CR10770: FL MAGNA/1401 LIGHT SHIELD
• D813CR10750: FL MAGNA TACKING TIPS
• D813CR10740: FL MAGNA POWER ADAPTER