FDA.reportPublic FDA data

FUSSEN

Primary DI
06974566270129
Brand
FUSSEN
Company
Fussen Technology Co., Ltd.
Model
S10
Published
2025-11-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
06974566270129PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06974566270129069745662701296974566270129

GMDN Terms#

Term, Definition table
TermDefinition
Intraoral optical scanning systemAn assembly of electronic devices intended to use optical technology to capture digital topographical 3-D images of teeth, oral cavity structure and geometry, and bite relationship of a patient; it is typically in addition capable of detecting dental caries. It consists of a hand-held intraoral scanner with near infrared (NIR) and laser illumination, and a mobile unit with a user interface with display/controls. The resulting digital dental impressions may be used for CAD/CAM fabrication of dental restorations and orthodontic devices.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
543062347
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06974566270167FUSSENMatrix 7800 Configuration 22025-11-24
06974566270181FUSSENMatrix 7000 Configuration 22025-11-24
06974566271133FUSSENMatrix 7000 Configuration 12025-11-24
06974566271294FUSSENMatrix 7800 Configuration 12025-11-24
06974566270006FUSSENS60002023-09-08
06974566270020FUSSENS70002023-09-08
06974566270037FUSSENS7000 Premium2023-09-08
06974566270051FUSSENS65002023-09-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
07540209957659MicronMapperClaronav IncNOF2026-02-10
07540209957666MicronMapper EVOClaronav IncNOF2026-02-10
06970163089812SHINING 3D®Shining 3D Tech Co., Ltd.NOF2026-02-06
08800293009894R2 PhotogramMegagen Implant Co. LtdNOF2026-02-06
18800026700873i900 Series Single Use TipMedit Corp.NOF2026-02-03
06970163089546SHINING 3D®Shining 3D Tech Co., Ltd.NOF2026-01-31
06970163089553SHINING 3D®Shining 3D Tech Co., Ltd.NOF2026-01-31
06970163089560SHINING 3D®Shining 3D Tech Co., Ltd.NOF2026-01-31
06970163089577SHINING 3D®Shining 3D Tech Co., Ltd.NOF2026-01-31