FDA.reportPublic FDA data

Intra Oral Sensor

Primary DI
08809460309850
Brand
Intra Oral Sensor
Company
Dentium Co., Ltd
Model
IOX1
Catalog number
IOX1
Device description
Intra Oral Sensor (model: IOX 1 / IOX 2) is a medical device that acquires digital images by detecting subject information through X-rays.
Published
2020-08-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)
MUHSystem, X-Ray, Extraoral Source, Digital

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)Radiology2
MUHSystem, X-Ray, Extraoral Source, DigitalDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201247000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201247000Intraoral SensorDentium Co., Ltd (Ict Branch)2020-06-10MQB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809460309850PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809460309850088094603098508809460309850

GMDN Terms#

Term, Definition table
TermDefinition
Dental digital imaging sensor, intraoralAn analogue device that is temporarily placed in a patient's mouth to perform routine diagnostic dental imaging procedures. It uses analogue-to-digital conversion techniques to record the absorption pattern of x-ray beams used in the diagnosis and treatment of diseases of the jaw or oral cavity structures. The device is used in combination with the x-ray source (x-ray tube) that is located outside the patient's mouth during the imaging procedure; the resulting digital image is transmitted to a monitor or workstation.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+821064769603yrna@dentium.com

Regulatory Flags#

DUNS number
695504638
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809772430563bright CTICT-R02-1T2023-12-26
08809772430570bright CTICT-R02-1TC2023-12-26
08809772430587bright CTICT-R02-2T2023-12-26
08809772430594bright CTICT-R02-2TC2023-12-26
08809772430600bright CTICT-R02-2TS2023-12-26
08809772430617bright CTICT-R02-2TSC2023-12-26
08809460309836bright MCTICT-R01-M2021-04-22
08809544906340rainbow CTICT-R012021-04-22
08809544906357rainbow CTICT-R01-L2021-04-22
08809460309843iCTmotorWL-1WL-12020-09-11
08809460309867Intra Oral SensorIOX2IOX22020-08-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860009306110Cleartooth Digital X-RayCLEARTOOTH ELECTRONICS, INC.MUH2026-05-27
08800011200060Dental Digital X-ray Imaging DevicePOINTIMPLANT Co., Ltd.MUH2026-05-21
08800011200084Dental Digital X-ray Imaging DevicePOINTIMPLANT Co., Ltd.MUH2026-05-21
08800011150129DRGEMDRGEM CorporationMQB2026-05-20
08800011150136DRGEMDRGEM CorporationMQB2026-05-20
08809413811096ExamVue ApexJPI HEALTHCARE. CO., LTD.MQB2026-05-14
08809413811126ExamVue ApexJPI HEALTHCARE. CO., LTD.MQB2026-05-14
08809413811133ExamVue ApexJPI HEALTHCARE. CO., LTD.MQB2026-05-14
B225100000220Orthoscan TAU MVP 1515Ziehm-Orthoscan, Inc.MQB2026-04-30
B225100000230Orthoscan TAU MVP 2020Ziehm-Orthoscan, Inc.MQB2026-04-30
08809365280001SG HealthcareSG Healthcare Co., Ltd.MQB2026-04-24
08809365281015SG HealthcareSG Healthcare Co., Ltd.MQB2026-04-24
08055186671089A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLMQB2026-04-02
08800000500164Cocoon SoloDEXCOWIN CO., LTD.MUH2026-03-31
08033837936107NewTomCEFLA SOCIETA' COOPERATIVAMUH2026-03-13
00198953056103DefiniumGE Hualun Medical Systems Co., LtdMQB2026-02-12
00198953056158DefiniumGE Hualun Medical Systems Co., LtdMQB2026-02-12
08809244060335GenorayGENORAY CO., LTD.MUH2025-12-01
08809244060472GenorayGENORAY CO., LTD.MUH2025-12-01
00195278913814DefiniumGE Hualun Medical Systems Co., LtdMQB2025-09-05
08800011150112DRGEMDRGEM CorporationMQB2025-08-26
08800003027019RAYSCANRay Co., LtdMUH2025-08-25
08800003027033RAYSCANRay Co., LtdMUH2025-08-25
08800003027040RAYSCANRay Co., LtdMUH2025-08-25
B225100000200Orthoscan Versa Mini C-ArmZiehm-Orthoscan, Inc.MQB2025-07-11
08809244060243GenorayGENORAY CO., LTD.MUH2025-05-02
08809244060250GenorayGENORAY CO., LTD.MUH2025-03-24
08809244060281GenorayGENORAY CO., LTD.MUH2025-03-24
D0031000082900SchickDentsply International Inc.MQB2024-11-06
D0031000085860SchickDentsply International Inc.MQB2024-11-06