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

• 03598833235166 - EVANESCE: 2025-01-07 EVANESCE INJECTABLE ENW SYR
• 03598833235265 - EVANESCE: 2025-01-07 EVANESCE EVANESCE INJECTABLE
• 03598833235272 - EVANESCE: 2025-01-07 EVANESCE INJECTABLE A2U SYR
• 03598833235289 - EVANESCE: 2025-01-07 EVANESCE INJECTABLE B1U SYR
• 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