FDA.reportPublic FDA data

SHINING 3D®

Primary DI
06975338702473
Brand
SHINING 3D®
Company
Hangzhou SHINING3D Dental Technology Co., Ltd.
Model
CB200-A2(Nano,35g,3-pack)
Device description
LumiCera is used for fabricating permanent single crowns, permanent inlays and onlays, veneers, bridges.
Published
2026-03-30
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
EBFMaterial, Tooth Shade, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBFMaterial, Tooth Shade, ResinDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K260170000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K260170000LumiCeraHangzhou SHINING3D Dental Technology Co., Ltd.2026-01-21EBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06975338702473PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06975338702473069753387024736975338702473

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
06975338701087SHINING 3D®CX200-B1 (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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809518340651Once-Fil FlowMEDICLUS CO.,LTDEBF2026-05-28
08809518340668Once-Fil FlowMEDICLUS CO.,LTDEBF2026-05-28
08809254453875Dual CoreVERICOM CO., LTD.EBF2026-05-27
08809254453943Dual CoreVERICOM CO., LTD.EBF2026-05-27
07615208291964Tetric PrimeIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2023-02-23
07615208291971Tetric PrimeIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2023-02-23
07615208291988Tetric PrimeIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2023-02-23
07615208291995Tetric PrimeIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2023-02-23
07615208292008Tetric PrimeIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2023-02-23
07615208292015Tetric PrimeIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2023-02-23
07615208292022Tetric PrimeIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2023-02-23
07615208292039Tetric PrimeIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2023-02-23
07615208292046Tetric PrimeIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2023-02-23
07615208292053Tetric PrimeIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2023-02-23
07615208292060Tetric PrimeIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2023-02-23
07615208292077Tetric PrimeIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2023-02-23
07615208292084Tetric PrimeIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2023-02-23
07615208292091Tetric PrimeIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2023-02-23
07615208292107Tetric PrimeIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2023-02-23
07615208292114Tetric PrimeIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2023-02-23
07615208292121Tetric PrimeIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2023-02-23
07615208006605SR NexcoIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2022-08-23
07615208006162SR NexcoIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2022-08-22
07615208006179SR NexcoIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2022-08-22
07615208006186SR NexcoIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2022-08-22
07615208006193SR NexcoIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2022-08-22
07615208006209SR NexcoIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2022-08-22
07615208006216SR NexcoIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2022-08-22
07615208006223SR NexcoIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2022-08-22
07615208006230SR NexcoIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2022-08-22