NV PRO3 ZLR3003INT

GUDID D813ZLR3003INT0

NV PRO3 MICROLASER IT

DEN-MAT HOLDINGS, LLC

Dental diode laser system

• Primary Device ID: D813ZLR3003INT0
• NIH Device Record Key: d8764287-1c4b-44bf-a43c-775f9e36a51e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NV PRO3
• Version Model Number: ZLR3003INT
• Catalog Number: ZLR3003INT
• 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: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 6 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 6 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 6 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 6 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 6 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 6 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 6 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 6 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 6 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 6 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 6 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 6 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 6 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 6 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D813ZLR3003INT0 [Primary]

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: 2024-10-31
• Device Publish Date: 2024-10-23

Devices Manufactured by DEN-MAT HOLDINGS, LLC

• D813ZLR3003INT0 - NV PRO3: 2024-10-31NV PRO3 MICROLASER IT
• D813ZLR3003INT0 - NV PRO3: 2024-10-31 NV PRO3 MICROLASER IT
• D813ALED41INT0 - PeriOptix: 2024-09-27 MicroLine Mini Headlight System International
• D813ALED420 - PeriOptix: 2024-09-27 MicroLine Mini Headlight System
• D813ALED5990 - PeriOptix: 2024-09-27 Firefly Cordless Headlight System International
• D813ALED599B0 - PeriOptix: 2024-09-27 Firefly Cordless Headlight system Internatinal Blue
• D813ALED599R0 - PeriOptix: 2024-09-27 Firefly Cordless Headlight System International Red
• D813ALED6990 - PeriOptix: 2024-09-27 Lumipro Headlight System International
• D8130398114010 - TENURE: 2024-05-16 TENURE MPB SYSTEM BAG