SprintRay OnX Tough 2 - Hollywood White

GUDID 00850039704734

SprintRay OnX Tough 2 is a tooth shade ceramic-hybrid resin used for the fabrication of hybrid denture prosthetics, implant-supported denture prosthetics, monolithic full and partial removable dentures, and preformed denture teeth to be used in a denture.

Sprintray, Inc.

Dental appliance fabrication material, resin

• Primary Device ID: 00850039704734
• NIH Device Record Key: 7a72c6c4-d095-4871-947b-799de5d595df
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SprintRay OnX Tough 2 - Hollywood White
• Version Model Number: SRI-0202164
• Company DUNS: 063005260
• Company Name: Sprintray, 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: false
• Manufacturing Date: true
• Expiration Date: true
• 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: 800-914-8004
• Email: support@sprintray.com
• Phone: 800-914-8004
• Email: support@sprintray.com
• Phone: 800-914-8004
• Email: support@sprintray.com
• Phone: 800-914-8004
• Email: support@sprintray.com
• Phone: 800-914-8004
• Email: support@sprintray.com
• Phone: 800-914-8004
• Email: support@sprintray.com
• Phone: 800-914-8004
• Email: support@sprintray.com
• Phone: 800-914-8004
• Email: support@sprintray.com
• Phone: 800-914-8004
• Email: support@sprintray.com
• Phone: 800-914-8004
• Email: support@sprintray.com
• Phone: 800-914-8004
• Email: support@sprintray.com
• Phone: 800-914-8004
• Email: support@sprintray.com

Device Dimensions

• Weight: 500 Gram
• Weight: 500 Gram
• Weight: 500 Gram
• Weight: 500 Gram
• Weight: 500 Gram
• Weight: 500 Gram
• Weight: 500 Gram
• Weight: 500 Gram
• Weight: 500 Gram
• Weight: 500 Gram
• Weight: 500 Gram
• Weight: 500 Gram

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store OnX Tough 2 at 15-25oC (60-77oF) and avoid direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep the bottle closed and/or the tank lid securely attached when not in use
• Special Storage Condition, Specify: Between 0 and 0 *Before disposal, completely polymerize
• Special Storage Condition, Specify: Between 0 and 0 *Store OnX Tough 2 at 15-25oC (60-77oF) and avoid direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep the bottle closed and/or the tank lid securely attached when not in use
• Special Storage Condition, Specify: Between 0 and 0 *Before disposal, completely polymerize
• Special Storage Condition, Specify: Between 0 and 0 *Store OnX Tough 2 at 15-25oC (60-77oF) and avoid direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep the bottle closed and/or the tank lid securely attached when not in use
• Special Storage Condition, Specify: Between 0 and 0 *Before disposal, completely polymerize
• Special Storage Condition, Specify: Between 0 and 0 *Store OnX Tough 2 at 15-25oC (60-77oF) and avoid direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep the bottle closed and/or the tank lid securely attached when not in use
• Special Storage Condition, Specify: Between 0 and 0 *Before disposal, completely polymerize
• Special Storage Condition, Specify: Between 0 and 0 *Store OnX Tough 2 at 15-25oC (60-77oF) and avoid direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep the bottle closed and/or the tank lid securely attached when not in use
• Special Storage Condition, Specify: Between 0 and 0 *Before disposal, completely polymerize
• Special Storage Condition, Specify: Between 0 and 0 *Store OnX Tough 2 at 15-25oC (60-77oF) and avoid direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep the bottle closed and/or the tank lid securely attached when not in use
• Special Storage Condition, Specify: Between 0 and 0 *Before disposal, completely polymerize
• Special Storage Condition, Specify: Between 0 and 0 *Store OnX Tough 2 at 15-25oC (60-77oF) and avoid direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep the bottle closed and/or the tank lid securely attached when not in use
• Special Storage Condition, Specify: Between 0 and 0 *Before disposal, completely polymerize
• Special Storage Condition, Specify: Between 0 and 0 *Store OnX Tough 2 at 15-25oC (60-77oF) and avoid direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep the bottle closed and/or the tank lid securely attached when not in use
• Special Storage Condition, Specify: Between 0 and 0 *Before disposal, completely polymerize
• Special Storage Condition, Specify: Between 0 and 0 *Store OnX Tough 2 at 15-25oC (60-77oF) and avoid direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep the bottle closed and/or the tank lid securely attached when not in use
• Special Storage Condition, Specify: Between 0 and 0 *Before disposal, completely polymerize
• Special Storage Condition, Specify: Between 0 and 0 *Store OnX Tough 2 at 15-25oC (60-77oF) and avoid direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep the bottle closed and/or the tank lid securely attached when not in use
• Special Storage Condition, Specify: Between 0 and 0 *Before disposal, completely polymerize
• Special Storage Condition, Specify: Between 0 and 0 *Store OnX Tough 2 at 15-25oC (60-77oF) and avoid direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep the bottle closed and/or the tank lid securely attached when not in use
• Special Storage Condition, Specify: Between 0 and 0 *Before disposal, completely polymerize
• Special Storage Condition, Specify: Between 0 and 0 *Store OnX Tough 2 at 15-25oC (60-77oF) and avoid direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep the bottle closed and/or the tank lid securely attached when not in use
• Special Storage Condition, Specify: Between 0 and 0 *Before disposal, completely polymerize

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850039704734 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230445

FDA Product Code

• EBI: Resin, Denture, Relining, Repairing, Rebasing

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: 2024-04-01
• Device Publish Date: 2024-03-22

Devices Manufactured by Sprintray, Inc.

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• 00850070544429 - APEX Base - Original Pink - 3kg: 2025-03-27 SprintRay Apex Base resin is a light-curable polymerizable resin intended to be used for the fabrication and repair of full and
• 00850070544436 - APEX Base - Dark Reddish Pink - 3kg: 2025-03-27 SprintRay Apex Base resin is a light-curable polymerizable resin intended to be used for the fabrication and repair of full and
• 00850070544443 - APEX Base - Opaque Original Pink - 3kg: 2025-03-27 SprintRay Apex Base resin is a light-curable polymerizable resin intended to be used for the fabrication and repair of full and
• 00850070544450 - OnX Tough 2 - A1 - 3kg: 2025-03-27 SprintRay OnX Tough 2 is a tooth shade ceramic-hybrid resin used for the fabrication of hybrid denture prosthetics, implant-supp
• 00850070544559 - OnX Tough 2 - A2 - 3kg: 2025-03-27 SprintRay OnX Tough 2 is a tooth shade ceramic-hybrid resin used for the fabrication of hybrid denture prosthetics, implant-supp
• 00850070544566 - OnX Tough 2 - B1 - 3kg: 2025-03-27 SprintRay OnX Tough 2 is a tooth shade ceramic-hybrid resin used for the fabrication of hybrid denture prosthetics, implant-supp
• 00850070544573 - OnX Tough 2 - Bleach - 3kg: 2025-03-27 SprintRay OnX Tough 2 is a tooth shade ceramic-hybrid resin used for the fabrication of hybrid denture prosthetics, implant-supp