SprintRay High Impact Denture Base - Light Pink

Primary DI
00850039704185
Brand
SprintRay High Impact Denture Base - Light Pink
Company
Sprintray, Inc.
Model
SRI-0202038
Device description
SprintRay High Impact Denture Base is a light-curable polymerizable resin intended to be used for the fabrication and repair of full and partial removable dentures and baseplates.
Published
2023-01-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EBIResin, Denture, Relining, Repairing, Rebasing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBIResin, Denture, Relining, Repairing, RebasingDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K221678000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221678000SprintRay High Impact Denture BaseSprintray, Inc.2022-11-10EBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850039704182PackageGS11In Commercial Distribution
00850039704185PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085003970418210850039704182
00850039704185008500397041858500397041850850039704185

GMDN Terms#

Term, Definition table
TermDefinition
Dental appliance fabrication material, resinA resin intended to be used in the dental laboratory to manufacture a patient-worn dental prosthesis or appliance (e.g., denture base, occlusal splint/night guard), that either: 1) polymerizes under heat (heat-cured), light (light-cured), and/or after a period of time (self-cured); or 2) can be shaped by a dental mill [e.g., based on computer-aided design/computer-aided manufacturing (CAD/CAM) technology]. It may in addition be intended to fabricate non-patient-worn devices (e.g., drilling templates using 3-D printing). After application, this material cannot be refabricated.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume1Liter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not store in an oxygen-free environment. Avoid freezing the material.
Special Storage Condition, Specify00Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials. Do not store near high temperatures, light or ignition sources.

Contacts#

Phone, Email table
PhoneEmail
800-914-8004support@sprintray.com

Regulatory Flags#

DUNS number
063005260
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810222900022OnX Tough 2 - A1 - Multi-Unit Capsule 3-PackSRI-02041972026-04-08
00810222900039OnX Tough 2 - Bleach - Multi-Unit Capsule 3-PackSRI-02042002026-04-08
00850070544740Crown HT - A1 - Multi-unit Capsule 1-PackSRI-02042422026-04-08
00850070544757Crown HT - A2 - Multi-unit Capsule 1-PackSRI-02042432026-04-08
00850070544764Digital Temp - A1 - Multi-Unit Capsule 1-PackSRI-02042162026-04-08
00850070544771Digital Temp - A2 - Multi-Unit Capsule 1-PackSRI-02042172026-04-08
00850070544788OnX Tough 2 - A1 - Multi-Unit Capsule 1-PackSRI-02042302026-04-08
00850070544795OnX Tough 2 - Bleach - Multi-Unit Capsule 1-PackSRI-02042332026-04-08
00850070544887Digital Temp - A1 - Multi-Unit Capsule 3-PackSRI-02041832026-04-08
00850070544931Crown HT - A1 - Multi-Unit Capsule 3-PackSRI-02042092026-04-08
00850070544948Crown HT - A2 - Multi-Unit Capsule 3-PackSRI-02042102026-04-08
00850070544993Digital Temp - A2 - Multi-Unit Capsule 3-PackSRI-02041842026-04-08
00850070544832IDB 3 SRI-02022192026-03-17
00850070544825Precision GuideSRI-02021892026-03-03
00850070544597APEX Flex - Standard PinkSRI-02021872025-07-21
00850070544603APEX Flex - Light PinkSRI-02021882025-07-21
00850070544320SprintRay Crown - A1 - Single-unit CapsuleSRI-02040922025-05-27
00850070544337SprintRay Crown - A2 - Single-unit CapsuleSRI-02040932025-05-27
00850070544344SprintRay Crown - A3 - Single-unit CapsuleSRI-02040942025-05-27
00850070544351SprintRay Crown - B1 - Single-unit CapsuleSRI-02040952025-05-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D14307560147448040Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.EBI2026-05-29
D14307560147448110Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.EBI2026-05-29
D14307560147448280Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.EBI2026-05-29
D14307560147448350Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.EBI2026-05-29
D14307560147449650Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.EBI2026-05-29
D14307560147450090Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.EBI2026-05-29
D14307560147450160Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.EBI2026-05-29
D14307560147451840Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.EBI2026-05-29
07615208482775ProBase Hot / ProBase ColdIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBI2026-04-30
08056640078369major.base 20MAJOR PRODOTTI DENTARI SPAEBI2026-04-27
08056640078857major.repairMAJOR PRODOTTI DENTARI SPAEBI2026-04-27
07701126631194Opti-Cryl Pour Acrylic Original X 22 lbPRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S AEBI2026-04-23
EPRC66100851dima Print Denture Base 2pro3dure medical GmbHEBI2025-07-31
08435288443584IDODENTINEUNION DENTAL SAEBI2025-07-30
08435288443591IDODENTINEUNION DENTAL SAEBI2025-07-30
08435288443614IDODENTINEUNION DENTAL SAEBI2025-07-30
08435288443645IDODENTINEUNION DENTAL SAEBI2025-07-30
08435288443669IDODENTINEUNION DENTAL SAEBI2025-07-30
08435288443690IDODENTINEUNION DENTAL SAEBI2025-07-30
08435288443607IDODENTINEUNION DENTAL SAEBI2024-11-27
08435288443621IDODENTINEUNION DENTAL SAEBI2024-11-27
08435288443638IDODENTINEUNION DENTAL SAEBI2024-11-27
08435288443652IDODENTINEUNION DENTAL SAEBI2024-11-27
08435288443676IDODENTINEUNION DENTAL SAEBI2024-11-27
08435288443683IDODENTINEUNION DENTAL SAEBI2024-11-27
EPOLPMMP10090Pink CAD/CAM DiscPOLIDENT d.o.o.EBI2024-10-17
EPOLPMMP10100Pink CAD/CAM DiscPOLIDENT d.o.o.EBI2024-10-17
EPOLPMMP10110Pink CAD/CAM DiscPOLIDENT d.o.o.EBI2024-10-17
EPOLPMMP10120Pink CAD/CAM DiscPOLIDENT d.o.o.EBI2024-10-17
EPOLPMMP10130Pink CAD/CAM DiscPOLIDENT d.o.o.EBI2024-10-17