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Found 6 results
510(k) Data Aggregation
K Number
K250617Device Name
Apex Flex
Manufacturer
SprintRay Inc.
Date Cleared
2025-04-29
(60 days)
Product Code
EBI
Regulation Number
872.3760Why did this record match?
Applicant Name (Manufacturer) :
SprintRay Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
Device Description
SprintRay Apex Flex is a photo-polymeric methacrylate/acrylate resin material used in conjunction with a 3D printer and a scanned 3D image in a dental office to fabricate partial dentures by 3D printing layer upon layer of the composite material. The product is available in two shades: Light Pink and Standard Pink.
SprintRay Apex Flex resin is intended exclusively for professional dental work. Fabrication of dental prosthetics with SprintRay Apex Flex resin requires computer-aided design and CAD/CAM manufacturing system that includes the following components not part of the device: Apex Flex file created in an optical impression system, 3D printer, and curing light equipment.
Apex Flex resin is designed to meet appropriate ISO standards for flexibility and sorption, to withstand prolonged use in the oral cavity. It is delivered non-sterile, and instructions on curing, and cleaning the final device prior to providing it to a patient are provided in the device indication for use document.
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K Number
K242559Device Name
Digital Temp
Manufacturer
SprintRay Inc.
Date Cleared
2024-11-26
(90 days)
Product Code
EBG
Regulation Number
872.3770Why did this record match?
Applicant Name (Manufacturer) :
SprintRay Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
Device Description
SprintRay Digital Temp is a photo-polymer methacrylate resin material used in conjunction with a 3D printer and a scanned 3D image in a dental office to build dental prosthetics by 3D printing layer of the composite material. SprintRay Digital Temp resin is offered in various shades such as Bleach, A1, A2 and B1. Digital Temp is an alternative to traditional dental prosthesis material that is intended exclusively for professional dental work.
SprintRay Digital Temp resin is intended exclusively for professional dental work. Fabrication of dental prosthetics with SprintRay Digital Temp resin requires computer-aided design and CAD/CAM manufacturing system that includes the following components not part of the device: Digital Temp file created in an optical impression system, 3D printer, and curing light equipment.
Digital Temp resin is designed to meet appropriate ISO standards for flexibility and sorption, to withstand prolonged use in the oral cavity. It is delivered nonsterile, and instructions on curing, and cleaning the final device prior to providing it to a patient are provided in the device indication for use document.
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K Number
K242277Device Name
Crown HT
Manufacturer
SprintRay Inc.
Date Cleared
2024-10-01
(61 days)
Product Code
EBF, EBG, EBI, ELM, PZY
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
SprintRay Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
Device Description
SprintRay Crown HT is a photo-polymer methacrylate resin material used in conjunction with a 3D printer and a scanned 3D image in a dental office to build dental prosthetics by 3D printing layer upon layer of the composite material. SprintRay Crown HT resin is offered in various shades such as Bleach. A1, A2, A3, and B1. Crown HT is an alternative to traditional dental prosthesis material that is intended exclusively for professional dental work.
SprintRay Crown HT resin is intended exclusively for professional dental work. Fabrication of dental prosthetics with SprintRay Crown HT resin requires computer-aided design and CAD/CAM manufacturing system that includes the following components not part of the device: Crown HT file created in an optical impression system, 3D printer, and curing light equipment.
Crown HT resin is designed to meet appropriate ISO standards for flexibility and sorption, to withstand prolonged use in the oral cavity. It is delivered non-sterile, and instructions on curing, and cleaning the final device prior to providing it to a patient are provided in the device instruction for use (IFU) document.
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K Number
K230445Device Name
OnX Tough
Manufacturer
SprintRay Inc.
Date Cleared
2023-07-14
(143 days)
Product Code
EBI, PZY
Regulation Number
872.3760Why did this record match?
Applicant Name (Manufacturer) :
SprintRay Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SprintRay OnX Tough 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.
Device Description
OnX Tough resin consists of a curable dental acrylate resin that is manufactured in a dental office based on a 3D scanned image of a patient's teeth. The acrylate resin material is designed to be used in conjunction with a scanned 3D image, and 3D printer assembly, to locally manufacture out a dental appliance based on the clinician's judgment of patient need.
Fabrication of dental prosthetics with OnX Tough resin requires computer-aided design and CAD/CAM manufacturing system that includes the following components not part of the device: oral casting impression, digital denture file created in an optical impression system, 3D printer, and curing light equipment.
The material is an alternative to traditional dental prostheses material. OnX Tough resin is intended exclusively for professional dental work.
OnX Tough resin is designed to meet appropriate ISO standards for flexibility and sorption, to withstand prolonged use in the oral cavity. It is delivered non-sterile, and instructions are provided on cleaning the material prior to providing it to a patient. Curing is performed with a UV lamp. The appliance is then cleaned, trimmed, and verified to fit in the dental office before the patient leaves.
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K Number
K222623Device Name
Digital Crown
Manufacturer
SprintRay Inc.
Date Cleared
2022-12-14
(105 days)
Product Code
EBF, EBI, ELM
Regulation Number
872.3690Why did this record match?
Applicant Name (Manufacturer) :
SprintRay Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SprintRay Digital 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.
Device Description
SprintRay Digital Crown resin consists of a curable dental acrylate resin that is manufactured in a dental office based on a 3D scanned image of a patient's teeth. The acrylate resin material is designed to be used in conjunction with a scanned 3D image, and 3D printer assembly, to locally manufacture out a dental appliance based on the clinician's judgment of patient need.
Fabrication of dental prosthetics with SprintRay Digital Crown resin requires computer-aided design and CAD/CAM manufacturing system that includes the following components not part of the device: oral casting impression, digital crown file created in an optical impression system, 3D printer, and curing light equipment. SprintRay Digital Crown Resin is intended exclusively for professional dental work. Digital Crown Resin is offered in following shades/colors: Bleach, A1, B1.
The device is manufactured via additive manufacturing process using a 3D printer with 405 nm wavelength, 50 m print layer thickness, and light energy of 28.8 mW/cm².
Digital Crown resin is designed to meet appropriate ISO standards for flexibility and sorption, to withstand prolonged use in the oral cavity. It is delivered nonsterile, and instructions are provided on cleaning the material prior to providing it to a patient. Curing is performed with a UV lamp. The appliance is then cleaned, trimmed, and verified to fit in the dental office before the patient leaves.
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K Number
K221678Device Name
SprintRay High Impact Denture Base
Manufacturer
SprintRay Inc.
Date Cleared
2022-11-10
(154 days)
Product Code
EBI
Regulation Number
872.3760Why did this record match?
Applicant Name (Manufacturer) :
SprintRay Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SprintRay High Impact Denture Base resin is a light-curable polymerizable resin intended to be used for the fabrication and repair, of full and partial removable dentures and baseplates. The material is an alternative to traditional denture base material.
Device Description
Fabrication of dental prosthetics with High Impact Denture Base resin requires computer-aided design and manufacturing system that includes the following components not part of the device: oral casting impression, digital denture base file created in an optical impression system, 3D printer, and curing light equipment.
The High Impact Denture Base consists of a curable dental acrylate resin that is designed to be used in conjunction with a scanned 3D image of a patient's teeth, and 3D printer assembly, to locally manufacture out a dental appliance in dental offices based on the clinician's judgment of patient need.
High Impact Denture Base Resin is intended exclusively for professional dental work. SprintRay High Impact Denture Base Resin is offered in following shades/colors:
- Light Pink .
- Original Pink ●
- . Light Meharry
- Original Meharry .
- . Dark Meharry
High Impact Denture Base is designed to meet appropriate ISO standards for flexibility, sorption, and solubility to withstand prolonged use in the oral cavity. It is delivered non-sterile, and instructions are provided on cleaning the material prior to providing it to a patient. Curing is performed with a UV lamp. The appliance is then cleaned, trimmed, and verified to fit in the dental office before the patient leaves.
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