| Primary Device ID | 00850070544566 |
| NIH Device Record Key | 72be49e5-a00e-49ad-8517-94ac9c498410 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OnX Tough 2 - B1 - 3kg |
| Version Model Number | SRI-0202197 |
| 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 | |
| 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 | |
| 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 |
| Weight | 3 Kilogram |
| Weight | 3 Kilogram |
| Weight | 3 Kilogram |
| Weight | 3 Kilogram |
| Weight | 3 Kilogram |
| Weight | 3 Kilogram |
| Weight | 3 Kilogram |
| Weight | 3 Kilogram |
| Weight | 3 Kilogram |
| Weight | 3 Kilogram |
| Weight | 3 Kilogram |
| Weight | 3 Kilogram |
| Weight | 3 Kilogram |
| Weight | 3 Kilogram |
| Weight | 3 Kilogram |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850070544566 [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 | 2025-03-27 |
| Device Publish Date | 2025-03-19 |
| 00850070544412 - APEX Base - Light 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 |
| 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 | 2025-03-27SprintRay 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. |
| 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 |