SOL® LR1045

GUDID D813LR10450

KT SOL WIRELESS UPGRADE

DEN-MAT HOLDINGS, LLC

Dental diode laser system

• Primary Device ID: D813LR10450
• NIH Device Record Key: d414042a-11f2-4d3e-8e52-af3e0976d47d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SOL®
• Version Model Number: LR1045
• Catalog Number: LR1045
• 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

• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D813LR10450 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141838

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-11-08
• Device Publish Date: 2016-09-24

On-Brand Devices [SOL®]

• D813LR10450: KT SOL WIRELESS UPGRADE
• D813LR10101: SOL/SAPH ASSY 300um TIP 25pc
• D813LR10040: SOL FOOT PEDAL ASSY
• D813LR1001WL0: SOL WIRELESS LOANER
• D813LR1001W0: SOL LASER SYSTEM INTG WIRELESS
• D813LR1001L0: SOL LASER SYSTEM INTG LOANER
• D813LR1001DW0: SOL LASER INTG WIRELESS-DEALER
• D813LR100060: SOL HANDPIECE REPLACEMENT KIT
• D81303398002801: SOL/SAPH LSR 400um TIPS 25pc
• D813LR1008CCD0: CC LASER SAFETY GLASSES
• D813LR10080: LASER EYEWEAR
• D813LR1001WINT0: SOL INTEGRATED WIRLESS IT