FDA.reportPublic FDA data

Ceramic Crown - A1 - Single-unit Capsule 3-Pack

Primary DI
00850039704871
Brand
Ceramic Crown - A1 - Single-unit Capsule 3-Pack
Company
Sprintray, Inc.
Model
SRI-0204010
Device description
SprintRay Ceramic Crown 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.
Published
2024-09-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EBFMaterial, Tooth Shade, Resin
EBIResin, Denture, Relining, Repairing, Rebasing
ELMDenture, Plastic, Teeth

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBFMaterial, Tooth Shade, ResinDental2
EBIResin, Denture, Relining, Repairing, RebasingDental2
ELMDenture, Plastic, TeethDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K222623000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222623000Digital CrownSprintray, Inc.2022-12-14EBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850039704871PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850039704871008500397048718500397048710850039704871

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 Volume12Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not use Ceramic Crown after the expiration date printed on the bottle
Special Storage Condition, Specify00Keep the bottle closed and/or the tank lid securely attached when not in use
Special Storage Condition, Specify00Resin must be protected from exposure to light, as spontaneous polymerization is possible. The bottle must be tightly closed after every usage.
Special Storage Condition, Specify00Store Ceramic Crown at 15-25oC (60-77oF) and avoid direct sunlight

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
063005260
Device count
1
Lot or batch
true
Manufacturing date on label
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
EGEB290040TRIBOS 501 C Composite teeth SLA-UJ-3,5Gebdi Dental-Products GmbHELM2026-06-03
00348783000931MultiMatchPREMIER DENTAL PRODUCTS COMPANYEBF2026-06-02
00348783000955MultiMatchPREMIER DENTAL PRODUCTS COMPANYEBF2026-06-02
00348783000979MultiMatchPREMIER DENTAL PRODUCTS COMPANYEBF2026-06-02
00348783000993MultiMatchPREMIER DENTAL PRODUCTS COMPANYEBF2026-06-02
00348783001044MultiMatchPREMIER DENTAL PRODUCTS COMPANYEBF2026-06-02
00348783001051MultiMatchPREMIER DENTAL PRODUCTS COMPANYEBF2026-06-02
06975338702916SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338702923SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338702930SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
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06975338703012SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338703029SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338703074SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338703081SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338703098SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338703104SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338703357SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338703364SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338703371SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338703388SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
00348783000917MultiMatchPREMIER DENTAL PRODUCTS COMPANYEBF2026-06-01
D14307560147448040Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.EBI2026-05-29
D14307560147448040Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.EBF2026-05-29
D14307560147448110Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.EBI2026-05-29
D14307560147448110Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.EBF2026-05-29
D14307560147448280Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.EBI2026-05-29
D14307560147448280Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.EBF2026-05-29