FDA.reportPublic FDA data

SHINING 3D®

Primary DI
06970163089447
Brand
SHINING 3D®
Company
Shining 3D Tech Co., Ltd.
Model
Atip EAS
Published
2026-01-01
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
06970163089447PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970163089447069701630894476970163089447

Sterilization Methods#

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

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
06942799001193SHINING 3D®AGR-AB2026-11-01
06942799001209SHINING 3D®AGR-AL2026-11-01
06942799001216SHINING 3D®AGR-AS2026-11-01
06942799001117SHINING 3D®Aoralscan Elf Pro2026-10-15
06970163080369SHINING 3D®Atip LS2026-10-15
06970163080406SHINING 3D®Atip LL2026-10-15
06970163089904SHINING 3D®Atip EIB2026-10-15
06970163089911SHINING 3D®Atip EIL2026-10-15
06970163089959SHINING 3D®Atip EIS2026-10-15
06942799001100SHINING 3D®HACS Kit2026-10-09
06942799000820Marathon®Aoralscan Elf2026-07-30
06942799000837Marathon®Atip LFB2026-07-30
06942799000844Marathon®Atip LFL2026-07-30
06942799000851Marathon®Atip LFS2026-07-30
06970163088693SHINING 3D®Aoralscan Elf Pro2026-07-21
06942799000004SHINING 3D®HACS-IPG(D40-B)2026-07-13
06942799000035SHINING 3D®HACS-IPG(D60M2-A)2026-07-13
06942799000042SHINING 3D®CS-A40-B2026-07-13
06942799000073SHINING 3D®CS-A60M2-A2026-07-13
06942799000080SHINING 3D®SH-40B2026-07-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06942799001193SHINING 3D®Shining 3D Tech Co., Ltd.NOF2026-11-01
06942799001209SHINING 3D®Shining 3D Tech Co., Ltd.NOF2026-11-01
06942799001216SHINING 3D®Shining 3D Tech Co., Ltd.NOF2026-11-01
06973993440440SprintRay Foundation HandpieceAlliedstar Medical Equipment Co., Ltd.NOF2026-10-23
06973993442758SprintRay Foundation ScannerAlliedstar Medical Equipment Co., Ltd.NOF2026-10-23
06973993443212SprintRay Foundation Charging DockAlliedstar Medical Equipment Co., Ltd.NOF2026-10-23
06973993443229SprintRay Foundation Scanner Tip (2pcs)Alliedstar Medical Equipment Co., Ltd.NOF2026-10-23
06942799001117SHINING 3D®Shining 3D Tech Co., Ltd.NOF2026-10-15
06970163080369SHINING 3D®Shining 3D Tech Co., Ltd.NOF2026-10-15
06970163080406SHINING 3D®Shining 3D Tech Co., Ltd.NOF2026-10-15
06970163089904SHINING 3D®Shining 3D Tech Co., Ltd.NOF2026-10-15
06970163089911SHINING 3D®Shining 3D Tech Co., Ltd.NOF2026-10-15
06970163089959SHINING 3D®Shining 3D Tech Co., Ltd.NOF2026-10-15
E27668907712Single use sleeve Primescan BoxSIRONA Dental Systems GmbHNOF2026-09-22
00860016329201OriOri IncNOF2026-08-21
06975456120005UP3D Intraoral ScannerShenzhen UP3d Technology Co., Ltd.NOF2026-08-19
04262352354897DS Core RestoZetta25 AGNOF2026-08-14
00693856000340DEXIS Imprevo SLIM TIPDental Imaging Technologies CorporationNOF2026-08-07
06942799000820Marathon®Shining 3D Tech Co., Ltd.NOF2026-07-30
06942799000837Marathon®Shining 3D Tech Co., Ltd.NOF2026-07-30
06942799000844Marathon®Shining 3D Tech Co., Ltd.NOF2026-07-30
06942799000851Marathon®Shining 3D Tech Co., Ltd.NOF2026-07-30
06970163088693SHINING 3D®Shining 3D Tech Co., Ltd.NOF2026-07-21
08800019601081LS-100-TIPHuvitz Co., Ltd.NOF2026-07-17
08800019601128LSO-100-TIPHuvitz Co., Ltd.NOF2026-07-17
08800019601135LSO-100-TIPHuvitz Co., Ltd.NOF2026-07-17
06430035421077Planmeca OnyxPlanmeca OyNOF2026-06-24
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