sprintray.comApex Flex
Sprintray, Inc.
SPRINTRAY INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3014289665 | 3014289665 | SPRINTRAY INC. | 1 | Y | 2026-01-01 | 2710, 2705 Media Center Dr Suite #100A Los Angeles CA US 90065 |
| 3024749697 | 3024749697 | SPRINTRAY INC. | 1 | N | 2026-01-01 | 17601 Sampson Ln. Huntington Beach CA US 92647 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00810222900022 | OnX Tough 2 - A1 - Multi-Unit Capsule 3-Pack - 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. | 800-914-8004 | support@sprintray.com |
| 00810222900039 | OnX Tough 2 - Bleach - Multi-Unit Capsule 3-Pack - 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. | 8009148004 | support@sprintray.com |
| 00810222900060 | SportsGuard - Crimson Red - SprintRay Sports Guard resin is a light-curable, polymerizable material intended for the fabrication of appliances that cover the teeth and adjacent oral tissues to help prevent or reduce trauma to teeth, gingiva, lips, and jaws during athletic or recreational activities. | 800-914-8004 | support@sprintray.com |
| 00810222900077 | SportsGuard - Cobalt Blue - SprintRay Sports Guard resin is a light-curable, polymerizable material intended for the fabrication of appliances that cover the teeth and adjacent oral tissues to help prevent or reduce trauma to teeth, gingiva, lips, and jaws during athletic or recreational activities. | 800-914-8004 | support@sprintray.com |
| 00810222900084 | SportsGuard - Clear - SprintRay Sports Guard resin is a light-curable, polymerizable material intended for the fabrication of appliances that cover the teeth and adjacent oral tissues to help prevent or reduce trauma to teeth, gingiva, lips, and jaws during athletic or recreational activities. | 800-914-8004 | support@sprintray.com |
| 00850070544740 | Crown HT - A1 - Multi-unit Capsule 1-Pack - SprintRay Crown HT is a light-curable polymerizable resin intended to be used for the fabrication of; individual and fixed definitive full single crowns; definitive partial crowns in anterior and posterior area, individual and fixed single veneers; artificial teeth for dental prostheses, which are used for removable definitive full dentures; and individual and removable monolithic full and partial dentures in dental offices and laboratories. The material is an alternative to traditional restorative dental material. | 800-914-8004 | support@sprintray.com |
| 00850070544757 | Crown HT - A2 - Multi-unit Capsule 1-Pack - SprintRay Crown HT is a light-curable polymerizable resin intended to be used for the fabrication of; individual and fixed definitive full single crowns; definitive partial crowns in anterior and posterior area, individual and fixed single veneers; artificial teeth for dental prostheses, which are used for removable definitive full dentures; and individual and removable monolithic full and partial dentures in dental offices and laboratories. The material is an alternative to traditional restorative dental material. | 800-914-8004 | support@sprintray.com |
| 00850070544764 | Digital Temp - A1 - Multi-Unit Capsule 1-Pack - SprintRay Digital Temp is a light-curable resin indicated for the fabrication of individual and fixed temporary full single crowns, temporary partial crowns, and temporary bridges. The material is an alternative to traditional restorative dental material. | 800-914-8004 | support@sprintray.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 310492 | 2018244328 | K260661 | Midas Restore | EBF | 2026-04-15 |
| 226772 | 2018244328 | K260661 | Midas Restore | EBF | 2026-04-15 |
| 310492 | 1031224556 | K250617 | Apex Flex | EBI | 2025-04-29 |
| 226772 | 1031224556 | K250617 | Apex Flex | EBI | 2025-04-29 |
| 226772 | 1806560340 | K242559 | Digital Temp | EBG | 2024-11-26 |
| 310492 | 1806560340 | K242559 | Digital Temp | EBG | 2024-11-26 |
| 310492 | 1644847384 | K242277 | Crown HT | EBF | 2024-10-01 |
| 226772 | 1644847384 | K242277 | Crown HT | EBF | 2024-10-01 |
| 310492 | 1302903343 | K230445 | OnX Tough | EBI | 2023-07-14 |
| 226772 | 1302903343 | K230445 | OnX Tough | EBI | 2023-07-14 |
| 226772 | 1877591758 | K222623 | Digital Crown | EBF | 2022-12-14 |
| 310492 | 1877591758 | K222623 | Digital Crown | EBF | 2022-12-14 |
| 226772 | 1490877475 | K221678 | SprintRay High Impact Denture Base | EBI | 2022-11-10 |
| 310492 | 1490877475 | K221678 | SprintRay High Impact Denture Base | EBI | 2022-11-10 |
| 226772 | 1705097166 | K220979 | SprintRay Denture Base | EBI | 2022-09-14 |
| 310492 | 1705097166 | K220979 | SprintRay Denture Base | EBI | 2022-09-14 |
| 226772 | 1643513785 | K212448 | NightGuard Flex | MQC | 2021-11-12 |
| 310492 | 1643513785 | K212448 | NightGuard Flex | MQC | 2021-11-12 |
| 226772 | 1108747816 | ||||
| 226772 | 1248819619 | ||||
| 226772 | 1266191602 | ||||
| 226772 | 1390737015 | ||||
| 226772 | 1447015628 | ||||
| 226772 | 1028892611 | ||||
| 310492 | 1028892611 | ||||
| 310492 | 1108747816 | ||||
| 310492 | 1182846074 | ||||
| 226772 | 1182846074 | ||||
| 310492 | 1213193980 | ||||
| 226772 | 1213193980 | ||||
| 310492 | 1447015628 | ||||
| 310492 | 1487303434 | ||||
| 226772 | 1487303434 |
Product Codes Associated With Registrations#
PMN#
Digital Temp
Sprintray, Inc.
Crown HT
Sprintray, Inc.
OnX Tough
Sprintray, Inc.
Digital Crown
Sprintray, Inc.
SprintRay High Impact Denture Base
SprintRay Inc.
SprintRay Denture Base
SprintRay Inc
NightGuard Flex
SprintRay Inc
GUDID#
SportsGuard - Crimson Red - SprintRay Sports Guard resin is a light-curable, polymerizable material intended for the fabrication of appliances that cover the teeth and adjacent oral tissues to help prevent or reduce trauma to teeth, gingiva, lips, and jaws during athletic or recreational activities.
2026-06-23
SportsGuard - Cobalt Blue - SprintRay Sports Guard resin is a light-curable, polymerizable material intended for the fabrication of appliances that cover the teeth and adjacent oral tissues to help prevent or reduce trauma to teeth, gingiva, lips, and jaws during athletic or recreational activities.
2026-06-23
SportsGuard - Clear - SprintRay Sports Guard resin is a light-curable, polymerizable material intended for the fabrication of appliances that cover the teeth and adjacent oral tissues to help prevent or reduce trauma to teeth, gingiva, lips, and jaws during athletic or recreational activities.
2026-06-23
OnX Tough 2 - A1 - Multi-Unit Capsule 3-Pack - 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.
2026-04-08
OnX Tough 2 - Bleach - Multi-Unit Capsule 3-Pack - 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.
2026-04-08
Crown HT - A1 - Multi-unit Capsule 1-Pack - SprintRay Crown HT is a light-curable polymerizable resin intended to be used for the fabrication of; individual and fixed definitive full single crowns; definitive partial crowns in anterior and posterior area, individual and fixed single veneers; artificial teeth for dental prostheses, which are used for removable definitive full dentures; and individual and removable monolithic full and partial dentures in dental offices and laboratories. The material is an alternative to traditional restorative dental material.
2026-04-08
Crown HT - A2 - Multi-unit Capsule 1-Pack - SprintRay Crown HT is a light-curable polymerizable resin intended to be used for the fabrication of; individual and fixed definitive full single crowns; definitive partial crowns in anterior and posterior area, individual and fixed single veneers; artificial teeth for dental prostheses, which are used for removable definitive full dentures; and individual and removable monolithic full and partial dentures in dental offices and laboratories. The material is an alternative to traditional restorative dental material.
2026-04-08
Digital Temp - A1 - Multi-Unit Capsule 1-Pack - SprintRay Digital Temp is a light-curable resin indicated for the fabrication of individual and fixed temporary full single crowns, temporary partial crowns, and temporary bridges. The material is an alternative to traditional restorative dental material.
2026-04-08
Digital Temp - A2 - Multi-Unit Capsule 1-Pack - SprintRay Digital Temp is a light-curable resin indicated for the fabrication of individual and fixed temporary full single crowns, temporary partial crowns, and temporary bridges. The material is an alternative to traditional restorative dental material.
2026-04-08
OnX Tough 2 - A1 - Multi-Unit Capsule 1-Pack - 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.
2026-04-08
OnX Tough 2 - Bleach - Multi-Unit Capsule 1-Pack - 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.
2026-04-08
Digital Temp - A1 - Multi-Unit Capsule 3-Pack - SprintRay Digital Temp is a light-curable resin indicated for the fabrication of individual and fixed temporary full single crowns, temporary partial crowns, and temporary bridges. The material is an alternative to traditional restorative dental material.
2026-04-08
Crown HT - A1 - Multi-Unit Capsule 3-Pack - SprintRay Crown HT is a light-curable polymerizable resin intended to be used for the fabrication of; individual and fixed definitive full single crowns; definitive partial crowns in anterior and posterior area, individual and fixed single veneers; artificial teeth for dental prostheses, which are used for removable definitive full dentures; and individual and removable monolithic full and partial dentures in dental offices and laboratories. The material is an alternative to traditional restorative dental material.
2026-04-08
Crown HT - A2 - Multi-Unit Capsule 3-Pack - SprintRay Crown HT is a light-curable polymerizable resin intended to be used for the fabrication of; individual and fixed definitive full single crowns; definitive partial crowns in anterior and posterior area, individual and fixed single veneers; artificial teeth for dental prostheses, which are used for removable definitive full dentures; and individual and removable monolithic full and partial dentures in dental offices and laboratories. The material is an alternative to traditional restorative dental material.
2026-04-08
Digital Temp - A2 - Multi-Unit Capsule 3-Pack - SprintRay Digital Temp is a light-curable resin indicated for the fabrication of individual and fixed temporary full single crowns, temporary partial crowns, and temporary bridges. The material is an alternative to traditional restorative dental material.
2026-04-08
IDB 3 - SprintRay IDB 3 is a light-curable polymerizable resin intended to be used for the fabrication of indirect bonding trays. This material is an alternative to traditional IBT material.
2026-03-17
Precision Guide - SPRINTRAY 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.
2026-03-03
APEX Flex - Standard Pink - SprintRay Apex Flex is an alternative to traditional thermoplastic material used for the fabrication and repair of partial dentures. It is intended exclusively for professional dental work.
2025-07-21
APEX Flex - Light Pink - SprintRay APEX Flex is an alternative to traditional thermoplastic material used for the fabrication and repair of partial dentures. It is intended exclusively for professional dental work.
2025-07-21
SprintRay Crown - A1 - Single-unit Capsule - SprintRay Crown is a light-curable polymerizable resin intended to be used for the fabrication of; individual and fixed definitive full single crowns; definitive partial crowns in anterior and posterior area, individual and fixed single veneers; artificial teeth for dental prostheses, which are used for removable definitive full dentures; and individual and removable monolithic full and partial dentures in dental offices and laboratories. The material is an alternative to traditional restorative dental material.
2025-05-27
SprintRay Crown - A2 - Single-unit Capsule - SprintRay Crown is a light-curable polymerizable resin intended to be used for the fabrication of; individual and fixed definitive full single crowns; definitive partial crowns in anterior and posterior area, individual and fixed single veneers; artificial teeth for dental prostheses, which are used for removable definitive full dentures; and individual and removable monolithic full and partial dentures in dental offices and laboratories. The material is an alternative to traditional restorative dental material.
2025-05-27
SprintRay Crown - A3 - Single-unit Capsule - SprintRay Crown is a light-curable polymerizable resin intended to be used for the fabrication of; individual and fixed definitive full single crowns; definitive partial crowns in anterior and posterior area, individual and fixed single veneers; artificial teeth for dental prostheses, which are used for removable definitive full dentures; and individual and removable monolithic full and partial dentures in dental offices and laboratories. The material is an alternative to traditional restorative dental material.
2025-05-27
SprintRay Crown - B1 - Single-unit Capsule - SprintRay Crown is a light-curable polymerizable resin intended to be used for the fabrication of; individual and fixed definitive full single crowns; definitive partial crowns in anterior and posterior area, individual and fixed single veneers; artificial teeth for dental prostheses, which are used for removable definitive full dentures; and individual and removable monolithic full and partial dentures in dental offices and laboratories. The material is an alternative to traditional restorative dental material.
2025-05-27
SprintRay Crown - Bleach - Single-unit Capsule - SprintRay Crown is a light-curable polymerizable resin intended to be used for the fabrication of; individual and fixed definitive full single crowns; definitive partial crowns in anterior and posterior area, individual and fixed single veneers; artificial teeth for dental prostheses, which are used for removable definitive full dentures; and individual and removable monolithic full and partial dentures in dental offices and laboratories. The material is an alternative to traditional restorative dental material.
2025-05-27
SprintRay Crown - C2 - Single-unit Capsule - SprintRay Crown is a light-curable polymerizable resin intended to be used for the fabrication of; individual and fixed definitive full single crowns; definitive partial crowns in anterior and posterior area, individual and fixed single veneers; artificial teeth for dental prostheses, which are used for removable definitive full dentures; and individual and removable monolithic full and partial dentures in dental offices and laboratories. The material is an alternative to traditional restorative dental material.
2025-05-27
SprintRay Crown - D2 - Single-unit Capsule - SprintRay Crown is a light-curable polymerizable resin intended to be used for the fabrication of; individual and fixed definitive full single crowns; definitive partial crowns in anterior and posterior area, individual and fixed single veneers; artificial teeth for dental prostheses, which are used for removable definitive full dentures; and individual and removable monolithic full and partial dentures in dental offices and laboratories. The material is an alternative to traditional restorative dental material.
2025-05-27
SprintRay Crown - D3 - Single-unit Capsule - SprintRay Crown is a light-curable polymerizable resin intended to be used for the fabrication of; individual and fixed definitive full single crowns; definitive partial crowns in anterior and posterior area, individual and fixed single veneers; artificial teeth for dental prostheses, which are used for removable definitive full dentures; and individual and removable monolithic full and partial dentures in dental offices and laboratories. The material is an alternative to traditional restorative dental material.
2025-05-27
SprintRay Crown - A1 - Single-unit Capsule 3-Pack - SprintRay Crown is a light-curable polymerizable resin intended to be used for the fabrication of; individual and fixed definitive full single crowns; definitive partial crowns in anterior and posterior area, individual and fixed single veneers; artificial teeth for dental prostheses, which are used for removable definitive full dentures; and individual and removable monolithic full and partial dentures in dental offices and laboratories. The material is an alternative to traditional restorative dental material.
2025-05-27
SprintRay Crown - A2 - Single-unit Capsule 3-Pack - SprintRay Crown is a light-curable polymerizable resin intended to be used for the fabrication of; individual and fixed definitive full single crowns; definitive partial crowns in anterior and posterior area, individual and fixed single veneers; artificial teeth for dental prostheses, which are used for removable definitive full dentures; and individual and removable monolithic full and partial dentures in dental offices and laboratories. The material is an alternative to traditional restorative dental material.
2025-05-27
SprintRay Crown - A3 - Single-unit Capsule 3-Pack - SprintRay Crown is a light-curable polymerizable resin intended to be used for the fabrication of; individual and fixed definitive full single crowns; definitive partial crowns in anterior and posterior area, individual and fixed single veneers; artificial teeth for dental prostheses, which are used for removable definitive full dentures; and individual and removable monolithic full and partial dentures in dental offices and laboratories. The material is an alternative to traditional restorative dental material.
2025-05-27
SprintRay Crown - B1 - Single-unit Capsule 3-Pack - SprintRay Crown is a light-curable polymerizable resin intended to be used for the fabrication of; individual and fixed definitive full single crowns; definitive partial crowns in anterior and posterior area, individual and fixed single veneers; artificial teeth for dental prostheses, which are used for removable definitive full dentures; and individual and removable monolithic full and partial dentures in dental offices and laboratories. The material is an alternative to traditional restorative dental material.
2025-05-27
SprintRay Crown - Bleach - Single-unit Capsule 3-Pack - SprintRay Crown is a light-curable polymerizable resin intended to be used for the fabrication of; individual and fixed definitive full single crowns; definitive partial crowns in anterior and posterior area, individual and fixed single veneers; artificial teeth for dental prostheses, which are used for removable definitive full dentures; and individual and removable monolithic full and partial dentures in dental offices and laboratories. The material is an alternative to traditional restorative dental material.
2025-05-27
SprintRay Crown - C2 - Single-unit Capsule 3-Pack - SprintRay Crown is a light-curable polymerizable resin intended to be used for the fabrication of; individual and fixed definitive full single crowns; definitive partial crowns in anterior and posterior area, individual and fixed single veneers; artificial teeth for dental prostheses, which are used for removable definitive full dentures; and individual and removable monolithic full and partial dentures in dental offices and laboratories. The material is an alternative to traditional restorative dental material.
2025-05-27
SprintRay Crown - D2 - Single-unit Capsule 3-Pack - SprintRay Crown is a light-curable polymerizable resin intended to be used for the fabrication of; individual and fixed definitive full single crowns; definitive partial crowns in anterior and posterior area, individual and fixed single veneers; artificial teeth for dental prostheses, which are used for removable definitive full dentures; and individual and removable monolithic full and partial dentures in dental offices and laboratories. The material is an alternative to traditional restorative dental material.
2025-05-27
SprintRay Crown - D3 - Single-unit Capsule 3-Pack - SprintRay Crown is a light-curable polymerizable resin intended to be used for the fabrication of; individual and fixed definitive full single crowns; definitive partial crowns in anterior and posterior area, individual and fixed single veneers; artificial teeth for dental prostheses, which are used for removable definitive full dentures; and individual and removable monolithic full and partial dentures in dental offices and laboratories. The material is an alternative to traditional restorative dental material.
2025-05-27
Crown - Bleach - SprintRay Crown is a light-curable polymerizable resin intended to be used for the fabrication of; individual and fixed definitive full single crowns; definitive partial crowns in anterior and posterior area, individual and fixed single veneers; artificial teeth for dental prostheses, which are used for removable definitive full dentures; and individual and removable monolithic full and partial dentures in dental offices and laboratories. The material is an alternative to traditional restorative dental material.
2024-08-19
Crown - A1 - SprintRay Crown is a light-curable polymerizable resin intended to be used for the fabrication of; individual and fixed definitive full single crowns; definitive partial crowns in anterior and posterior area, individual and fixed single veneers; artificial teeth for dental prostheses, which are used for removable definitive full dentures; and individual and removable monolithic full and partial dentures in dental offices and laboratories. The material is an alternative to traditional restorative dental material.
2024-08-19
Crown - B1 - SprintRay Crown is a light-curable polymerizable resin intended to be used for the fabrication of; individual and fixed definitive full single crowns; definitive partial crowns in anterior and posterior area, individual and fixed single veneers; artificial teeth for dental prostheses, which are used for removable definitive full dentures; and individual and removable monolithic full and partial dentures in dental offices and laboratories. The material is an alternative to traditional restorative dental material.
2024-08-19
Crown - A2 - SprintRay Crown is a light-curable polymerizable resin intended to be used for the fabrication of; individual and fixed definitive full single crowns; definitive partial crowns in anterior and posterior area, individual and fixed single veneers; artificial teeth for dental prostheses, which are used for removable definitive full dentures; and individual and removable monolithic full and partial dentures in dental offices and laboratories. The material is an alternative to traditional restorative dental material.
2024-08-19
Crown - A3 - SprintRay Crown is a light-curable polymerizable resin intended to be used for the fabrication of; individual and fixed definitive full single crowns; definitive partial crowns in anterior and posterior area, individual and fixed single veneers; artificial teeth for dental prostheses, which are used for removable definitive full dentures; and individual and removable monolithic full and partial dentures in dental offices and laboratories. The material is an alternative to traditional restorative dental material.
2024-08-19