FDA.reportPublic FDA data

SHINING 3D®

Primary DI
06975338700394
Brand
SHINING 3D®
Company
Hangzhou SHINING3D Dental Technology Co., Ltd.
Model
CB21-A3
Published
2025-12-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EBFMaterial, Tooth Shade, Resin
EBGCrown And Bridge, Temporary, Resin
PZYAdditively Manufactured, Preformed, Resin Denture Tooth

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBFMaterial, Tooth Shade, ResinDental2
EBGCrown And Bridge, Temporary, ResinDental2
PZYAdditively Manufactured, Preformed, Resin Denture ToothDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K253053000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K253053000Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1)Hangzhou SHINING3D Dental Technology Co., Ltd.2025-09-23EBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06975338700394PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06975338700394069753387003946975338700394

GMDN Terms#

Term, Definition table
TermDefinition
Custom-made dental crown, polymerA device made entirely of polymer-based material with or without fibre reinforcement, and created for a specific post-pubescent/adult patient (custom-made), that functions as an artificial covering to replace the major part, or the whole part, of the clinical crown of a tooth.

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
06942201775735FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-15
06942201776015FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-15
06942201776206FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-15
00810111543644QuantiumBISCO INC.EBF2026-10-12
00810222900206SprintRay Crown HT A1 Single-Unit Capsule - JapanSprintray, Inc.PZY2026-10-09
00810222900206SprintRay Crown HT A1 Single-Unit Capsule - JapanSprintray, Inc.EBG2026-10-09
00810222900206SprintRay Crown HT A1 Single-Unit Capsule - JapanSprintray, Inc.EBF2026-10-09
00810222900213SprintRay Crown HT A2 Single-Unit Capsule - JPSprintray, Inc.PZY2026-10-09
00810222900213SprintRay Crown HT A2 Single-Unit Capsule - JPSprintray, Inc.EBG2026-10-09
00810222900213SprintRay Crown HT A2 Single-Unit Capsule - JPSprintray, Inc.EBF2026-10-09
00810222900220SprintRay Crown HT Bleach Single-Unit Capsule - JPSprintray, Inc.PZY2026-10-09
00810222900220SprintRay Crown HT Bleach Single-Unit Capsule - JPSprintray, Inc.EBG2026-10-09
00810222900220SprintRay Crown HT Bleach Single-Unit Capsule - JPSprintray, Inc.EBF2026-10-09
00810222900237SprintRay Crown HT B1 Single-Unit Capsule - JPSprintray, Inc.EBF2026-10-09
00810222900237SprintRay Crown HT B1 Single-Unit Capsule - JPSprintray, Inc.PZY2026-10-09
00810222900237SprintRay Crown HT B1 Single-Unit Capsule - JPSprintray, Inc.EBG2026-10-09
00810222900244SprintRay Crown HT B1 Single-Unit Capsule 3-Pack - JPSprintray, Inc.PZY2026-10-09
00810222900244SprintRay Crown HT B1 Single-Unit Capsule 3-Pack - JPSprintray, Inc.EBG2026-10-09
00810222900244SprintRay Crown HT B1 Single-Unit Capsule 3-Pack - JPSprintray, Inc.EBF2026-10-09
00810222900251SprintRay Crown HT Bleach Single-Unit Capsule 3-Pack - JPSprintray, Inc.PZY2026-10-09
00810222900251SprintRay Crown HT Bleach Single-Unit Capsule 3-Pack - JPSprintray, Inc.EBG2026-10-09
00810222900251SprintRay Crown HT Bleach Single-Unit Capsule 3-Pack - JPSprintray, Inc.EBF2026-10-09
00810222900268SprintRay Crown HT A3 Single-Unit Capsule - JPSprintray, Inc.PZY2026-10-09
00810222900268SprintRay Crown HT A3 Single-Unit Capsule - JPSprintray, Inc.EBF2026-10-09
00810222900268SprintRay Crown HT A3 Single-Unit Capsule - JPSprintray, Inc.EBG2026-10-09
00810222900275SprintRay Crown HT A3 Single-unit Capsule 3-Pack - JPSprintray, Inc.PZY2026-10-09
00810222900275SprintRay Crown HT A3 Single-unit Capsule 3-Pack - JPSprintray, Inc.EBG2026-10-09
00810222900275SprintRay Crown HT A3 Single-unit Capsule 3-Pack - JPSprintray, Inc.EBF2026-10-09
00810222900282SprintRay Crown HT Unpigmented Single-Unit Capsule - JPSprintray, Inc.PZY2026-10-09
00810222900282SprintRay Crown HT Unpigmented Single-Unit Capsule - JPSprintray, Inc.EBG2026-10-09