FDA.reportPublic FDA data

EzRay Air 2 Wall

Primary DI
08800016401905
Brand
EzRay Air 2 Wall
Company
VATECH CO., LTD.
Model
VEX-S350W
Device description
VEX-S350W X-RAY SYSTEM(450MM)/EZRAY AIR2 W(USA)/MASTER
Published
2023-06-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EHDUnit, X-Ray, Extraoral With Timer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EHDUnit, X-Ray, Extraoral With TimerDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K223058000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223058000EzRay Air 2 Wall (Model: VEX-S350W)VATECH Co., Ltd.2022-10-26EHD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800016401905PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800016401905088000164019058800016401905

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held intraoral dental x-ray system, digitalA diagnostic dental x-ray system designed to generate and control x-ray beams. It records the absorption pattern of x-ray beams used for general-purpose, routine, dental radiography examinations involving the diagnosis and treatment (e.g., surgical or interventional) of diseases of the teeth, jaw and oral cavity structures. It is designed to be easily carried from location to location by a single operator. The sensor is placed in the mouth, the purpose being to visualize a limited region in detail. The data is either from analogue imaging and digitized afterwards or by digital imaging.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure86 KiloPascal106 KiloPascal
Handling Environment Humidity10 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius35 Degrees Celsius
Storage Environment Atmospheric Pressure86 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
689229516
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800016401974Green X 21PHT-90CHO2025-11-12
08800016401981Green X 21PHT-90CHO2025-11-12
08800016401950VistaPano S 2.0VistaPano S2024-12-13
08800016401967VistaPano S Ceph 2.0VistaPano S Ceph2024-12-13
08800016400304ProVecta S-PanProVecta S-Pan2016-09-16
08800016400311ProVecta S-PanProVecta S-Pan2016-09-16
08800016400328ProVecta HDProVecta HD2016-09-16
08800016400335ProVecta HDProVecta HD2016-09-16
08800016400342ProVecta HDProVecta HD2016-09-16
08800016401875VistaIntra DCVistaIntra DC2023-06-16
08800016401882VistaIntra DCVistaIntra DC2023-06-16
08800016401899VistaIntra DCVistaIntra DC2023-06-16
08800016400069PaX-i3D GreenPHT-60CFO2016-09-16
08800016400076PaX-i3D GreenPHT-60CFO2016-09-16
08800016400083PaX-i3D GreenPHT-60CFO2016-09-16
08800016400090PaX-i3D GreenPHT-60CFO2016-09-16
08800016400106PaX-i3D GreenPHT-60CFO2016-09-16
08800016400137PaX-i3D GreenPHT-60CFO2016-09-16
08800016400205PaX-i3DPHT-65002016-09-16
08800016400212PaX-i3DPHT-65002016-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D090800047970NOMAD Pro 3 X-Ray Tubehead, USDental Imaging Technologies CorporationEHD2026-03-31
D090800048750NOMAD Pro 3 Packaged System, USDental Imaging Technologies CorporationEHD2026-03-31
D090800048870NOMAD Pro 3 Packaged System, US Dental Imaging Technologies CorporationEHD2026-03-31
08809840720046WeRayPICOPACK Inc.EHD2024-10-24
08800021800045BIOXDigiMed Co., Ltd.EHD2024-06-12
08800021800106HYBRID S70DigiMed Co., Ltd.EHD2024-06-12
08800021800120XTG PRO 70DigiMed Co., Ltd.EHD2024-06-12
08800021800137DHX-70HDigiMed Co., Ltd.EHD2024-06-12
07899581344695EVOLVE SENSORAlliage S/A Indústrias Médico OdontológicaEHD2023-12-08
07899581344701EVOLVE SENSORAlliage S/A Indústrias Médico OdontológicaEHD2023-12-08
07899581340253Intraoral Dental Digital Imaging SensorAlliage S/A Indústrias Médico OdontológicaEHD2023-10-18
07899581340260Intraoral Dental Digital Imaging SensorAlliage S/A Indústrias Médico OdontológicaEHD2023-10-18
07899581340284Intraoral Dental Digital Imaging SensorAlliage S/A Indústrias Médico OdontológicaEHD2023-10-18
07899581340697Intraoral Dental Digital Imaging SensorAlliage S/A Indústrias Médico OdontológicaEHD2023-10-18
07899581340727Intraoral Dental Digital Imaging SensorAlliage S/A Indústrias Médico OdontológicaEHD2023-10-18
08800021800113xm-liteDigiMed Co., Ltd.EHD2022-12-01
08800124900000CLAROXVSI Co., Ltd.EHD2022-07-25
08800072313211Portable Dental X-ray (CS 2400P)NANORAY CO.,LTDEHD2021-02-18
08800072313310Portable Dental X-ray (CS 2300P)NANORAY CO.,LTDEHD2021-02-18
08800072313419Portable Dental X-ray (NR-F350 with Back scatter shield)NANORAY CO.,LTDEHD2021-02-18
08800072313518Portable Dental X-ray (R2 Port-X without Back scatter shield)NANORAY CO.,LTDEHD2021-02-18
08800072313617Portable Dental X-ray (R2 Port-X with Back scatter shield)NANORAY CO.,LTDEHD2021-02-18
D7641000083061XIOS AESIRONA DENTAL, INC.EHD2019-06-06
D7641000081680XIOS AESIRONA DENTAL, INC.EHD2019-06-05
D7641000081790XIOS AESIRONA DENTAL, INC.EHD2019-06-05
D7641000083480XIOS AESIRONA DENTAL, INC.EHD2019-06-05
08800040900047POSKOM Co., Ltd.Poskom Co., Ltd.EHD2018-06-19
D7641000064510Intraoral Sensor WallboxSIRONA DENTAL, INC.EHD2018-05-10
D7641000064561Intraoral Sensor WallboxSIRONA DENTAL, INC.EHD2018-05-10
D7641000064571Intraoral Sensor WallboxSIRONA DENTAL, INC.EHD2018-05-10