FDA.reportPublic FDA data

SHINING 3D®

Primary DI
06970163087733
Brand
SHINING 3D®
Company
Shining 3D Tech Co., Ltd.
Model
Atip LFB
Device description
This is an intraoral scanner that works with the supplied software programs. By performing scanning directly and digitally acquiring and saving the 2D/3D color images of teeth, gingiva and oral mucosa, the scanner is available for patients with needs of orthodontic, implant, and restoration.
Published
2025-09-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
NOFSystem, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NOFSystem, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental RestorationsDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06970163087733PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970163087733069701630877336970163087733

GMDN Terms#

Term, Definition table
TermDefinition
Dental milling system, CAD/CAM, chairsideAn assembly of devices designed for automated computer-aided design (CAD) and computer-aided manufacturing (CAM) of custom-made (prescribed for one patient) dental restorations produced chairside during dental or orthodontic treatment. It typically includes, or is used in conjunction with, three-dimensional (3-D) image acquisition and viewing capabilities that provide values (measurements) for the production phase; software for record collection, treatment planning, simulation and device production; and robotic capabilities for the production of the actual devices to be fitted to the patient.

Sterilization Methods#

Method table
Method
"[""Moist Heat or Steam Sterilization"", ""High-level Disinfectant""]"
Moist Heat or Steam Sterilization;High-level Disinfectant

Regulatory Flags#

DUNS number
529835314
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06970163089140SHINING 3D®SN3D-AI2026-05-20
06970163084022SHINING 3D®AGR-AB2026-05-11
06970163084039SHINING 3D®AGR-AL2026-05-11
06970163084046SHINING 3D®AGR-AS2026-05-11
06970163089966SHINING 3D®Aoralscan Elite Wireless2026-03-23
06970163089973SHINING 3D®Aoralscan Elite Wireless2026-03-23
06970163089836SHINING 3D®Cra LF2026-03-16
06970163089812SHINING 3D®Aoralscan Elite Wireless2026-02-06
06970163089782SHINING 3D®SH-40A2026-02-05
06970163089799SHINING 3D®SH-43B2026-02-05
06970163089805SHINING 3D®SH-38A2026-02-05
06970163089546SHINING 3D®Aoralscan Elite Wireless2026-01-31
06970163089553SHINING 3D®Atip EB2026-01-31
06970163089560SHINING 3D®Atip EL2026-01-31
06970163089577SHINING 3D®Atip ES2026-01-31
06970163089416SHINING 3D®Atip EAB2026-01-01
06970163089430SHINING 3D®Atip EAL2026-01-01
06970163089447SHINING 3D®Atip EAS2026-01-01
06970163089454SHINING 3D®QC-A2026-01-01
06970163089409SHINING 3D®Aoralscan Elf (TS)2025-12-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06970163089140SHINING 3D®Shining 3D Tech Co., Ltd.NOF2026-05-20
06975456126007UP3D Intraoral ScannerShenzhen UP3d Technology Co., Ltd.NOF2026-05-18
06970163084022SHINING 3D®Shining 3D Tech Co., Ltd.NOF2026-05-11
06970163084039SHINING 3D®Shining 3D Tech Co., Ltd.NOF2026-05-11
06970163084046SHINING 3D®Shining 3D Tech Co., Ltd.NOF2026-05-11
08800026700760Medit Link ExpressMedit Corp.NOF2026-04-28
08800026700883Medit Link ExpressMedit Corp.NOF2026-04-28
06973993442499Intraoral ScannerAlliedstar Medical Equipment Co., Ltd.NOF2026-04-20
00810060227053Blue Sky Bio, LLC.BLUE SKY BIO LLCNOF2026-04-13
06970163089966SHINING 3D®Shining 3D Tech Co., Ltd.NOF2026-03-23
06970163089973SHINING 3D®Shining 3D Tech Co., Ltd.NOF2026-03-23
06970163089836SHINING 3D®Shining 3D Tech Co., Ltd.NOF2026-03-16
D745701181MIL001610150fastdesign.ioPrismatik Dentalcraft, IncNOF2026-03-16
D745701181MIL046710150fastdesign.ioPrismatik Dentalcraft, IncNOF2026-03-16
07540209957482MicronMapperClaronav IncNOF2026-02-10
07540209957499MicronMapperClaronav IncNOF2026-02-10
07540209957505MicronMapperClaronav IncNOF2026-02-10
07540209957512MicronMapperClaronav IncNOF2026-02-10
07540209957529MicronMapperClaronav IncNOF2026-02-10
07540209957536MicronMapperClaronav IncNOF2026-02-10
07540209957543MicronMapperClaronav IncNOF2026-02-10
07540209957550MicronMapperClaronav IncNOF2026-02-10
07540209957567MicronMapperClaronav IncNOF2026-02-10
07540209957574MicronMapperClaronav IncNOF2026-02-10
07540209957581MicronMapperClaronav IncNOF2026-02-10
07540209957604MicronMapperClaronav IncNOF2026-02-10
07540209957611MicronMapperClaronav IncNOF2026-02-10
07540209957628MicronMapperClaronav IncNOF2026-02-10
07540209957635MicronMapperClaronav IncNOF2026-02-10
07540209957642MicronMapperClaronav IncNOF2026-02-10