Valo X 6496-LN

GUDID 00883205043269

VALO X Loaner Unit Red

ULTRADENT PRODUCTS, INC.

Dental/surgical polymerization lamp

• Primary Device ID: 00883205043269
• NIH Device Record Key: c2b5e835-6a6a-4e86-a525-ea7d29d033e3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Valo X
• Version Model Number: 6496-LN
• Catalog Number: 6496-LN
• Company DUNS: 013369913
• Company Name: ULTRADENT PRODUCTS, INC.
• 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: true
• 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: 801-572-4200
• Email: customerservice@ultradent.com
• Phone: 801-572-4200
• Email: customerservice@ultradent.com
• Phone: 801-572-4200
• Email: customerservice@ultradent.com
• Phone: 801-572-4200
• Email: customerservice@ultradent.com
• Phone: 801-572-4200
• Email: customerservice@ultradent.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00883205043269 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220471

FDA Product Code

• EBZ: Activator, Ultraviolet, For Polymerization

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: 2025-08-22
• Device Publish Date: 2025-08-14

On-Brand Devices [Valo X]

• 00883205043351: VALO X Black Demo
• 00883205043320: VALO X Black Demo
• 00883205043313: VALO X Loaner Unit Purple
• 00883205043306: VALO X Loaner Unit Blue
• 00883205043290: VALO X Loaner Unit Green
• 00883205043283: VALO X Loaner Unit Grey
• 00883205043276: VALO X Loaner Unit Pink
• 00883205043269: VALO X Loaner Unit Red
• 00883205042934: VALO X Black
• 00883205042927: VALO X Purple
• 00883205042910: VALO X Blue
• 00883205042903: VALO X Green
• 00883205042897: VALO X Grey
• 00883205042880: VALO X Pink
• 00883205042873: VALO X Red