FDA.reportPublic FDA data

SHINING 3D®

Primary DI
06975338700431
Brand
SHINING 3D®
Company
Hangzhou SHINING3D Dental Technology Co., Ltd.
Model
DT20-OR
Device description
Denture Base Resin is a light-curable polymerizable resin intended to be used for the fabrication of full and partial removable dentures. Fabrication of denture bases with Denture Base Resin requires a digital denture file, 3D printer and post-curing unit.
Published
2025-04-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K250946000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250946000Denture Base Resin DT20Hangzhou SHINING3D Dental Technology Co., Ltd.2025-03-31EBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06975338700431PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06975338700431069753387004316975338700431

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
406871432
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
06975338702916SHINING 3D®CB200-A1T(Nano,6g,3-pack)2026-06-02
06975338702923SHINING 3D®CB200-A2T(Nano,6g,3-pack)2026-06-02
06975338702930SHINING 3D®CB200-A3T(Nano,6g,3-pack)2026-06-02
06975338702947SHINING 3D®CB200-B1T(Nano,6g,3-pack)2026-06-02
06975338702992SHINING 3D®CB200-A1T(Nano,10g,3-pack)2026-06-02
06975338703005SHINING 3D®CB200-A2T(Nano,10g,3-pack)2026-06-02
06975338703012SHINING 3D®CB200-A3T(Nano,10g,3-pack)2026-06-02
06975338703029SHINING 3D®CB200-B1T(Nano,10g,3-pack)2026-06-02
06975338703074SHINING 3D®CB200-A1T(Nano,35g,3-pack)2026-06-02
06975338703081SHINING 3D®CB200-A2T(Nano,35g,3-pack)2026-06-02
06975338703098SHINING 3D®CB200-A3T(Nano,35g,3-pack)2026-06-02
06975338703104SHINING 3D®CB200-B1T(Nano,35g,3-pack)2026-06-02
06975338703357SHINING 3D®CB200-A1T (0.5kg/bottle)2026-06-02
06975338703364SHINING 3D®CB200-A2T (0.5kg/bottle)2026-06-02
06975338703371SHINING 3D®CB200-A3T (0.5kg/bottle)2026-06-02
06975338703388SHINING 3D®CB200-B1T (0.5kg/bottle)2026-06-02
06975338701063SHINING 3D®CX200-A1 (0.5kg/bottle)2026-05-11
06975338701070SHINING 3D®CX200-A2 (0.5kg/bottle)2026-05-11
06975338701087SHINING 3D®CX200-B1 (0.5kg/bottle)2026-05-11
06975338701094SHINING 3D®CX200-BL (0.5kg/bottle)2026-05-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842326128132DuraflexThe Myerson Company LimitedEBI2026-10-22
00842326128149DuraflexThe Myerson Company LimitedEBI2026-10-22
00842326128156DuraflexThe Myerson Company LimitedEBI2026-10-22
00842326128163DuraflexThe Myerson Company LimitedEBI2026-10-22
00842326128170DuraflexThe Myerson Company LimitedEBI2026-10-22
06942480719550FLNT BaseLiaoning Upcera Co.,Ltd.EBI2026-10-19
06942480719567FLNT BaseLiaoning Upcera Co.,Ltd.EBI2026-10-19
06942480720396FLNT BaseLiaoning Upcera Co.,Ltd.EBI2026-10-19
06942480720402FLNT BaseLiaoning Upcera Co.,Ltd.EBI2026-10-19
06942480720617FLNT BaseLiaoning Upcera Co.,Ltd.EBI2026-10-19
06942480720624FLNT BaseLiaoning Upcera Co.,Ltd.EBI2026-10-19
06942480721454FLNT BaseLiaoning Upcera Co.,Ltd.EBI2026-10-19
06942480721461FLNT BaseLiaoning Upcera Co.,Ltd.EBI2026-10-19
06942480722284FLNT BaseLiaoning Upcera Co.,Ltd.EBI2026-10-19
06942480722291FLNT BaseLiaoning Upcera Co.,Ltd.EBI2026-10-19
06942480722505FLNT BaseLiaoning Upcera Co.,Ltd.EBI2026-10-19
06942480722512FLNT BaseLiaoning Upcera Co.,Ltd.EBI2026-10-19
06942480723335FLNT BaseLiaoning Upcera Co.,Ltd.EBI2026-10-19
06942480723342FLNT BaseLiaoning Upcera Co.,Ltd.EBI2026-10-19
00810222900206SprintRay Crown HT A1 Single-Unit Capsule - JapanSprintray, Inc.EBI2026-10-09
00810222900213SprintRay Crown HT A2 Single-Unit Capsule - JPSprintray, Inc.EBI2026-10-09
00810222900220SprintRay Crown HT Bleach Single-Unit Capsule - JPSprintray, Inc.EBI2026-10-09
00810222900237SprintRay Crown HT B1 Single-Unit Capsule - JPSprintray, Inc.EBI2026-10-09
00810222900244SprintRay Crown HT B1 Single-Unit Capsule 3-Pack - JPSprintray, Inc.EBI2026-10-09
00810222900251SprintRay Crown HT Bleach Single-Unit Capsule 3-Pack - JPSprintray, Inc.EBI2026-10-09
00810222900268SprintRay Crown HT A3 Single-Unit Capsule - JPSprintray, Inc.EBI2026-10-09
00810222900275SprintRay Crown HT A3 Single-unit Capsule 3-Pack - JPSprintray, Inc.EBI2026-10-09
00810222900282SprintRay Crown HT Unpigmented Single-Unit Capsule - JPSprintray, Inc.EBI2026-10-09
00810222900299SprintRay Crown HT Unpigmented Single-unit Capsule 3-Pack - JPSprintray, Inc.EBI2026-10-09
00810222900305SprintRay Crown HT A1 Single-Unit Capsule 3-Pack - JPSprintray, Inc.EBI2026-10-09