FDA.reportPublic FDA data

SHINING 3D®

Primary DI
06975338701087
Brand
SHINING 3D®
Company
Hangzhou SHINING3D Dental Technology Co., Ltd.
Model
CX200-B1 (0.5kg/bottle)
Device description
The product is indicated for the fabrication, by additive manufacturing, of temporary dental restorations, and preformed denture teeth to be used in a denture.
Published
2026-05-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K261261000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K261261000Dura-ArchHangzhou SHINING3D Dental Technology Co., Ltd.2026-04-17EBG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06975338701087PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06975338701087069753387010876975338701087

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.

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
06975338701063SHINING 3D®CX200-A1 (0.5kg/bottle)2026-05-11
06975338701070SHINING 3D®CX200-A2 (0.5kg/bottle)2026-05-11
06975338701094SHINING 3D®CX200-BL (0.5kg/bottle)2026-05-11
06975338701599SHINING 3D®CB200-A1(Nano,6g,3-pack)2026-03-30
06975338701605SHINING 3D®CB200-A2(Nano,6g,3-pack)2026-03-30
06975338701612SHINING 3D®CB200-B1(Nano,6g,3-pack)2026-03-30
06975338701629SHINING 3D®CB200-C2(Nano,6g,3-pack)2026-03-30
06975338701636SHINING 3D®CB200-BL(Nano,6g,3-pack)2026-03-30
06975338702060SHINING 3D®CB200-A1 (0.5kg/bottle)2026-03-30
06975338702077SHINING 3D®CB200-A2 (0.5kg/bottle)2026-03-30
06975338702084SHINING 3D®CB200-B1 (0.5kg/bottle)2026-03-30
06975338702091SHINING 3D®CB200-BL (0.5kg/bottle)2026-03-30
06975338702107SHINING 3D®CB200-C2 (0.5kg/bottle)2026-03-30
06975338702268SHINING 3D®CB200-A1(Nano,10g,3-pack)2026-03-30
06975338702275SHINING 3D®CB200-A2(Nano,10g,3-pack)2026-03-30
06975338702282SHINING 3D®CB200-B1(Nano,10g,3-pack)2026-03-30
06975338702299SHINING 3D®CB200-C2(Nano,10g,3-pack)2026-03-30
06975338702305SHINING 3D®CB200-BL(Nano,10g,3-pack)2026-03-30
06975338702466SHINING 3D®CB200-A1(Nano,35g,3-pack)2026-03-30
06975338702473SHINING 3D®CB200-A2(Nano,35g,3-pack)2026-03-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
EPOLPMFLAG5600PMMA CAD/CAM discPOLIDENT d.o.o.EBG2025-05-13
EPOLPMMA1270PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-08
EPOLPMMA1350PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-08
EPOLPMMA1430PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-08
EPOLPMMA0230PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0310PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0390PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0470PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0550PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0630PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0710PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0790PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0870PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0950PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0070PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-04
EPOLPMMA1030PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-04
EPOLPMMA1110PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-04
EPOLPMMA1190PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-04
EPOLKML200160DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML200200DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML201160DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML201200DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML202160DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML202200DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML203160DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML203200DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML204160DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML204200DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML205160DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML205200DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02