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 Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin 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.

• 00850039704628 - SprintRay Nightguard Flex 2 - Simply Clear - 1 Kg: 2024-04-01 SprintRay NightGuard Flex 2 is indicated for the fabrication of dental appliances such as mouthguards and nightguards.
• 00850039704635 - SprintRay Nightguard Flex 2 - Ocean Blue - 1 Kg: 2024-04-01 SprintRay NightGuard Flex 2 is indicated for the fabrication of dental appliances such as mouthguards and nightguards.
• 00850039704642 - SprintRay Nightguard Firm 2 - Midnight Purple -1 Kg: 2024-04-01 SprintRay NightGuard Firm 2 is indicated for the fabrication of dental appliances such as mouthguards and nightguards.
• 00850039704734 - SprintRay OnX Tough 2 - Hollywood White: 2024-04-01SprintRay 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.
• 00850039704734 - SprintRay OnX Tough 2 - Hollywood White: 2024-04-01 SprintRay OnX Tough 2 is a tooth shade ceramic-hybrid resin used for the fabrication of hybrid denture prosthetics, implant-supp
• 10850039704168 - SprintRay NightGuard Firm: 2024-02-29 The material is an alternative to traditional dental prostheses material. SprintRay NightGuard Firm resin is intended exclusivel
• 10850039704236 - SprintRay Standard Denture Base - Light Pink: 2024-02-29 SprintRay Standard Denture Base is a light-curable polymerizable resin intended to be used for the fabrication and repair of ful
• 10850039704243 - SprintRay Standard Denture Base - Original Pink: 2024-02-29 SprintRay High Impact Denture Teeth is a light-curable polymerizable resin intended to be used to fabricate artificial teeth for
• 10850039704267 - SprintRay Standard Denture Base - Dark Meharry: 2024-02-29 SprintRay Standard Denture Base is a light-curable polymerizable resin intended to be used for the fabrication and repair of ful