VALO 4864

GUDID 00883205030900

VALO GRAND SAPPHIRE (Cordless)

ULTRADENT PRODUCTS, INC.

Dental/surgical polymerization lamp

• Primary Device ID: 00883205030900
• NIH Device Record Key: 3c96140f-4736-4163-aff6-682b41665278
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VALO
• Version Model Number: 4864
• Catalog Number: 4864
• 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: +1(801)572-4200
• Email: customerservice@ultradent.com
• Phone: +1(801)572-4200
• Email: customerservice@ultradent.com
• Phone: +1(801)572-4200
• Email: customerservice@ultradent.com
• Phone: +1(801)572-4200
• Email: customerservice@ultradent.com
• Phone: +1(801)572-4200
• Email: customerservice@ultradent.com
• Phone: +1(801)572-4200
• Email: customerservice@ultradent.com
• Phone: +1(801)572-4200
• Email: customerservice@ultradent.com
• Phone: +1(801)572-4200
• Email: customerservice@ultradent.com
• Phone: +1(801)572-4200
• Email: customerservice@ultradent.com
• Phone: +1(801)572-4200
• Email: customerservice@ultradent.com
• Phone: +1(801)572-4200
• Email: customerservice@ultradent.com
• Phone: +1(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
• 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
• 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	00883205030900 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160551

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: 2024-12-25
• Device Publish Date: 2024-12-17

On-Brand Devices [VALO]

• 00883205105103: VALO GRAND CORDLESS CURING LIGHT
• 00883205105097: VALO Curing Light Midwestern University
• 00883205105080: VALO Curing Light Hekadental
• 00883205105073: VALO Curing Light Roseman University
• 00883205105066: VALO Cordless Curing Light Teal
• 00883205105042: VALO Cordless Curing Light Fuchsia
• 00883205105035: VALO Cordless Curing Light Graphite
• 00883205105011: VALO Cordless Curing Light Gold
• 00883205105004: VALO Ortho Cordless Curing Light
• 00883205104984: VALO Ortho Cordless Curing Light
• 00883205104960: VALO Cordless Curing Light
• 00883205104946: VALO Cordless Curing Light
• 00883205104939: VALO Ortho Curing Light
• 00883205104915: VALO Ortho Curing Light
• 00883205104908: VALO PointCure Lens 2 pack
• 00883205104892: VALO 16ft Power Supply w/Universal Plugs
• 00883205104885: VALO Barrier Sleeve Refill
• 00883205104878: VALO Power Supply w/ Universal Plugs
• 00883205104861: VALO Cordless Light Shield
• 00883205104854: VALO International Enabled Units
• 00883205104847: VALO Curing Light for Internal Use
• 00883205104809: VALO Curing Light
• 00883205102997: ProxiCure Ball Lenses 2pk
• 00883205029393: Translume Lens Yellow
• 00883205029386: Translume Lens Orange
• 00883205029379: Proxicure Ball Regular
• 00883205029362: Proxicure Ball Small
• 00883205026057: VALO Corded Barrier Sleeve
• 00883205026040: VALO Cordless Barrier Sleeve
• 00883205020314: Valo Curing Light Bracket
• 00883205019608: VALO Light Shield
• 00883205019226: VALO Cordless Power Supply w/Universal Plugs
• 00883205019219: VALO GRAND CORDLESS CURING LIGHT
• 00883205015518: VALO Cordless Charger
• 00883205015501: VALO Cordless Batteries (Re-Chargeable) 2 Pk
• 00883205015495: VALO Black Light Lens
• 00883205004802: VALO Translume Lens 2 Pack
• 00883205004574: VALO EndoGuide Lens
• 00883205000026: VALO Cordless 500 Barrier Sleeves Refill
• 00883205110275: VALO GRAND Corded Curing Light
• 00883205101723: VALO GRAND Black Light Lens
• 00883205101686: VALO GRAND Translume Lens 2 Pack
• 00883205101662: VALO GRAND PointCure Lens 2 pack
• 00883205101655: VALO GRAND ProxiCure Ball Lenses 2pk
• 00883205031815: VALO GRAND Inter-Proximal Lens 2pk
• 00883205031808: VALO Inter-Proximal Lens 2pk
• 00883205031792: VALO GRAND White Light Lens 2pk
• 00883205034489: VALO X Batteries
• 00883205034472: VALO X Assembled Cord
• 00883205033154: VALO X Battery Charger