FDA.reportPublic FDA data

FUSSEN

Primary DI
06974566270167
Brand
FUSSEN
Company
Fussen Technology Co., Ltd.
Model
Matrix 7800 Configuration 2
Published
2025-11-24
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
OASX-Ray, Tomography, Computed, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OASX-Ray, Tomography, Computed, DentalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K251842000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251842000Dental Computed Tomography X-ray SystemFussen Technology Co., Ltd.2025-11-13OAS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06974566270167PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06974566270167069745662701676974566270167

GMDN Terms#

Term, Definition table
TermDefinition
Cone beam computed tomography system, head/neckA stationary assembly of mains electricity (AC-powered) devices intended to produce two- or three-dimensional (3-D) diagnostic digital x-ray images of the head/neck using cone beam computed tomography (CBCT). It consists of an x-ray source assembly, high-voltage generator, x-ray detector, processor, reconstruction software, and patient support device (e.g., seat, stabilizing bite block); the patient is typically scanned in an upright position by a rotating arm. It is typically intended for (but not limited to) dental and ear/nose/throat (ENT) applications.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
543062347
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
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
06974566270181FUSSENMatrix 7000 Configuration 22025-11-24
06974566271133FUSSENMatrix 7000 Configuration 12025-11-24
06974566271294FUSSENMatrix 7800 Configuration 12025-11-24
06974566270129FUSSENS102025-11-20
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
08033837936107NewTomCEFLA SOCIETA' COOPERATIVAOAS2026-03-13
E27668234260Primevision 3DSIRONA Dental Systems GmbHOAS2026-02-13
00990010312418DURAYBeyes Dental Canada IncOAS2025-12-15
00990010312562DURAYBeyes Dental Canada IncOAS2025-12-15
00990010312579DURAYBeyes Dental Canada IncOAS2025-12-15
00990010312586DURAYBeyes Dental Canada IncOAS2025-12-15
00990010312593DURAYBeyes Dental Canada IncOAS2025-12-15
00990010312609DURAYBeyes Dental Canada IncOAS2025-12-15
08800003027026RCT700Ray Co., LtdOAS2025-12-01
08809244060335GenorayGENORAY CO., LTD.OAS2025-12-01
08809244060472GenorayGENORAY CO., LTD.OAS2025-12-01
06974566270181FUSSENFussen Technology Co., Ltd.OAS2025-11-24
06974566271133FUSSENFussen Technology Co., Ltd.OAS2025-11-24
06974566271294FUSSENFussen Technology Co., Ltd.OAS2025-11-24
08800003027002RCT700Ray Co., LtdOAS2025-08-25
08800003027019RCT700Ray Co., LtdOAS2025-08-25
08800003027033RCT700Ray Co., LtdOAS2025-08-25
08800003027040RCT700Ray Co., LtdOAS2025-08-25
08800003027057RCT800Ray Co., LtdOAS2025-08-25
08800003027095RAYSCAN α-3DRay Co., LtdOAS2025-08-25
06430035875191ORTHOPANTOMOGRAPHâ„¢ OP 3DPaloDEx Group OyOAS2025-07-15
08809244060243GenorayGENORAY CO., LTD.OAS2025-05-02
08800000996042T2 PlusOsstem Implant Co.,Ltd.OAS2025-04-28
08800000996059T2 PlusOsstem Implant Co.,Ltd.OAS2025-04-28
08800003027064RCT600Ray Co., LtdOAS2025-04-14
08800003027071RCT600Ray Co., LtdOAS2025-04-14
08809244060250GenorayGENORAY CO., LTD.OAS2025-03-24
08809244060281GenorayGENORAY CO., LTD.OAS2025-03-24
06430035875184ORTHOPANTOMOGRAPHâ„¢ OP 3DPaloDEx Group OyOAS2025-03-11
06976117940017EighteethChangzhou Finno Medical Technology Co., Ltd.OAS2025-03-06