SprintRay OnX Tough 2 - A2 - 500g

GUDID 00850039704598

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: 00850039704598
• NIH Device Record Key: 2b33fda1-1c57-4e92-9124-45260e0864eb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SprintRay OnX Tough 2 - A2 - 500g
• Version Model Number: SRI-0202124
• 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
• 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
• 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
• 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
• 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
• 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
• 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 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store in an oxygen-free environment. Avoid freezing the material.
• Special Storage Condition, Specify: Between 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store in an oxygen-free environment. Avoid freezing the material.
• Special Storage Condition, Specify: Between 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store in an oxygen-free environment. Avoid freezing the material.
• Special Storage Condition, Specify: Between 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store in an oxygen-free environment. Avoid freezing the material.
• Special Storage Condition, Specify: Between 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store in an oxygen-free environment. Avoid freezing the material.
• Special Storage Condition, Specify: Between 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store in an oxygen-free environment. Avoid freezing the material.
• Special Storage Condition, Specify: Between 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store in an oxygen-free environment. Avoid freezing the material.
• Special Storage Condition, Specify: Between 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store in an oxygen-free environment. Avoid freezing the material.
• Special Storage Condition, Specify: Between 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store in an oxygen-free environment. Avoid freezing the material.
• Special Storage Condition, Specify: Between 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store in an oxygen-free environment. Avoid freezing the material.
• Special Storage Condition, Specify: Between 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store in an oxygen-free environment. Avoid freezing the material.
• Special Storage Condition, Specify: Between 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store in an oxygen-free environment. Avoid freezing the material.
• Special Storage Condition, Specify: Between 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store in an oxygen-free environment. Avoid freezing the material.
• Special Storage Condition, Specify: Between 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store in an oxygen-free environment. Avoid freezing the material.
• Special Storage Condition, Specify: Between 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store in an oxygen-free environment. Avoid freezing the material.
• Special Storage Condition, Specify: Between 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store in an oxygen-free environment. Avoid freezing the material.
• Special Storage Condition, Specify: Between 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store in an oxygen-free environment. Avoid freezing the material.
• Special Storage Condition, Specify: Between 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store in an oxygen-free environment. Avoid freezing the material.
• Special Storage Condition, Specify: Between 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store in an oxygen-free environment. Avoid freezing the material.
• Special Storage Condition, Specify: Between 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store in an oxygen-free environment. Avoid freezing the material.
• Special Storage Condition, Specify: Between 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store in an oxygen-free environment. Avoid freezing the material.
• Special Storage Condition, Specify: Between 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store in an oxygen-free environment. Avoid freezing the material.
• Special Storage Condition, Specify: Between 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store in an oxygen-free environment. Avoid freezing the material.
• Special Storage Condition, Specify: Between 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store in an oxygen-free environment. Avoid freezing the material.
• Special Storage Condition, Specify: Between 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store in an oxygen-free environment. Avoid freezing the material.
• Special Storage Condition, Specify: Between 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store in an oxygen-free environment. Avoid freezing the material.
• Special Storage Condition, Specify: Between 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store in an oxygen-free environment. Avoid freezing the material.
• Special Storage Condition, Specify: Between 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store in an oxygen-free environment. Avoid freezing the material.
• Special Storage Condition, Specify: Between 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store in an oxygen-free environment. Avoid freezing the material.
• Special Storage Condition, Specify: Between 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store in an oxygen-free environment. Avoid freezing the material.
• Special Storage Condition, Specify: Between 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store in an oxygen-free environment. Avoid freezing the material.
• Special Storage Condition, Specify: Between 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store in an oxygen-free environment. Avoid freezing the material.
• Special Storage Condition, Specify: Between 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store in an oxygen-free environment. Avoid freezing the material.
• Special Storage Condition, Specify: Between 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store in an oxygen-free environment. Avoid freezing the material.
• Special Storage Condition, Specify: Between 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store in an oxygen-free environment. Avoid freezing the material.
• Special Storage Condition, Specify: Between 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store in an oxygen-free environment. Avoid freezing the material.
• Special Storage Condition, Specify: Between 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store in an oxygen-free environment. Avoid freezing the material.
• Special Storage Condition, Specify: Between 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store in an oxygen-free environment. Avoid freezing the material.
• Special Storage Condition, Specify: Between 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store in an oxygen-free environment. Avoid freezing the material.
• Special Storage Condition, Specify: Between 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store in an oxygen-free environment. Avoid freezing the material.
• Special Storage Condition, Specify: Between 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store in an oxygen-free environment. Avoid freezing the material.
• Special Storage Condition, Specify: Between 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store in an oxygen-free environment. Avoid freezing the material.
• Special Storage Condition, Specify: Between 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store in an oxygen-free environment. Avoid freezing the material.
• Special Storage Condition, Specify: Between 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store in an oxygen-free environment. Avoid freezing the material.
• Special Storage Condition, Specify: Between 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store in an oxygen-free environment. Avoid freezing the material.
• Special Storage Condition, Specify: Between 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store in an oxygen-free environment. Avoid freezing the material.
• Special Storage Condition, Specify: Between 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store in an oxygen-free environment. Avoid freezing the material.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850039704598 [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: 2023-08-21
• Device Publish Date: 2023-08-11

Devices Manufactured by Sprintray, Inc.

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• 00850039704949 - OnX Tough 2 A1 Single-unit Capsule: 2024-12-17 SprintRay OnX Tough 2 is a tooth shade ceramic-hybrid resin used for the fabrication of hybrid denture prosthetics, implant-supp
• 00850039704956 - OnX Tough 2 A1 Single-unit Capsule 3-Pack: 2024-12-17 SprintRay OnX Tough 2 is a tooth shade ceramic-hybrid resin used for the fabrication of hybrid denture prosthetics, implant-supp
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• 00850039704758 - Ceramic Crown - A2 - Single-unit Capsule 1-Pack: 2024-09-17 SprintRay Ceramic Crown is a photo-polymer methacrylate resin material used in conjunction with a 3D printer and a scanned 3D im
• 00850039704765 - Ceramic Crown - B1 - Single-unit Capsule 1-Pack: 2024-09-17 SprintRay Ceramic Crown is a photo-polymer methacrylate resin material used in conjunction with a 3D printer and a scanned 3D im