| Primary Device ID | 00850039704925 |
| NIH Device Record Key | a7219199-49d7-4ef4-bd2e-2939917efb50 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OnX Tough 2 Bleach Single-unit Capsule |
| Version Model Number | SRI-0204061 |
| 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 |
| Phone | 800-914-8004 |
| support@sprintray.com | |
| Phone | 800-914-8004 |
| support@sprintray.com | |
| Phone | 800-914-8004 |
| support@sprintray.com | |
| Phone | 800-914-8004 |
| support@sprintray.com | |
| Phone | 800-914-8004 |
| support@sprintray.com |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| 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 *Resin must be protected from exposure to light, as spontaneous polymerization is possible. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use OnX Tough 2 after the expiration date |
| 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 *Resin must be protected from exposure to light, as spontaneous polymerization is possible. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use OnX Tough 2 after the expiration date |
| 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 *Resin must be protected from exposure to light, as spontaneous polymerization is possible. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use OnX Tough 2 after the expiration date |
| 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 *Resin must be protected from exposure to light, as spontaneous polymerization is possible. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use OnX Tough 2 after the expiration date |
| 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 *Resin must be protected from exposure to light, as spontaneous polymerization is possible. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use OnX Tough 2 after the expiration date |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850039704925 [Primary] |
| EBI | Resin, Denture, Relining, Repairing, Rebasing |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-12-17 |
| Device Publish Date | 2024-12-09 |
| 00850039704925 - OnX Tough 2 Bleach Single-unit Capsule | 2024-12-17SprintRay 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. |
| 00850039704925 - OnX Tough 2 Bleach 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 |
| 00850039704932 - OnX Tough 2 Bleach 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 |
| 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 |
| 00850039704918 - SprintRay Retainer | 2024-10-25 SprintRay Retainer is an alternative to traditional thermoplastic material used for the fabrication of retainers. It is intended |
| 00850039704741 - Ceramic Crown - A1 - 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 |
| 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 |