| Primary Device ID | 00850070544825 |
| NIH Device Record Key | cb0caba9-211c-48a7-8aa2-5f754b50de7d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Precision Guide |
| Version Model Number | SRI-0202189 |
| Company DUNS | 063005260 |
| Company Name | Sprintray, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850070544825 [Primary] |
| NDP | Accessories, Implant, Dental, Endosseous |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-03-11 |
| Device Publish Date | 2026-03-03 |
| 00850070544825 - Precision Guide | 2026-03-11SPRINTRAY PRECISION GUIDE IS A LIGHT-CURABLE POLYMERIZABLE RESIN INTENDED TO BE USED FOR FABRICATION OF SURGICAL GUIDES. THIS MATERIAL IS AN ALTERNATIVE TO TRADITIONAL SURGICAL GUIDE MATERIAL. |
| 00850070544825 - Precision Guide | 2026-03-11 SPRINTRAY PRECISION GUIDE IS A LIGHT-CURABLE POLYMERIZABLE RESIN INTENDED TO BE USED FOR FABRICATION OF SURGICAL GUIDES. THIS MA |
| 00850070544597 - APEX Flex - Standard Pink | 2025-07-29 SprintRay Apex Flex is an alternative to traditional thermoplastic material used for the fabrication and repair of partial dentu |
| 00850070544603 - APEX Flex - Light Pink | 2025-07-29 SprintRay APEX Flex is an alternative to traditional thermoplastic material used for the fabrication and repair of partial dentu |
| 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 |