BLUEWAVE LR1001WCCDEMO

GUDID D813LR1001WCCDEMO0

CCD LASER WIRELESS DEMO

DEN-MAT HOLDINGS, LLC

Dental diode laser system

• Primary Device ID: D813LR1001WCCDEMO0
• NIH Device Record Key: 850349d8-716d-40c6-a1c5-2018520a7def
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BLUEWAVE
• Version Model Number: LR1001WCCDEMO
• Catalog Number: LR1001WCCDEMO
• 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
• 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	D813LR1001WCCDEMO0 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-10-18
• Device Publish Date: 2019-10-10

On-Brand Devices [BLUEWAVE]

• D813LR1045CCD0: CCD LASER WIRELESS FOOT PEDAL
• D813LR1012CCD1: CCD DISP TIPS 4mm 25pc
• D813LR1010CCD1: CCD DISP PERIO TIPS 9mm 300um
• D813LR1001WCCDEMO0: CCD LASER WIRELESS DEMO
• D813LR1001WCCD0: CCD LASER WIRELESS
• D813LR10006CCD0: CCD LASER OPTIC CABLE w/HP