FDA.reportPublic FDA data

Gendex GXS-700™ intraoral sensor

Primary DI
EKAV100850520
Brand
Gendex GXS-700™ intraoral sensor
Company
GENDEX CORP.
Model
1.008.5052
Catalog number
GXS70012S
Device description
Size 1
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MUHSystem,x-ray,extraoral source,digital

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MUHSystem, X-Ray, Extraoral Source, DigitalDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K090458000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090458000DEXIS SENSORDexis, LLC2009-05-28MUH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EKAV100850520PrimaryHIBCC0

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
Handling Environment Temperature5 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+18003238029info@gendex.com

Regulatory Flags#

DUNS number
144575763
Device count
1
Kit
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
EKAV101291560KaVo GXS-700™ intraoral sensor1.012.91562022-01-21
EKAV101291570KaVo GXS-700™ intraoral sensor1.012.91572022-01-21
EKAV101291580KaVo GXS-700™ intraoral sensor1.012.91582022-01-21
EKAV101291590KaVo GXS-700™ intraoral sensor1.012.91592022-01-21
EKAV101291600KaVo GXS-700™ intraoral sensor1.012.91602022-01-21
EKAV101291610KaVo GXS-700™ intraoral sensor1.012.91612022-01-21
EKAV101305110KaVo GXS-700™ intraoral sensor1.013.05112022-01-21
EKAV101305120KaVo GXS-700™ intraoral sensor1.013.05122022-01-21
EKAV101305130KaVo GXS-700™ intraoral sensor1.013.05132022-01-21
EKAV101305140KaVo GXS-700™ intraoral sensor1.013.05142022-01-21
EKAV082243310Gendex GXC-300™ intraoral camera0.822.4331GXC3002016-09-24
EKAV082245980Gendex GXS-700™ intraoral sensor0.822.4598120 0211G12016-09-24
EKAV082245990Gendex GXS-700™ intraoral sensor0.822.4599120 0212G12016-09-24
EKAV082250110Gendex GXS-700™ intraoral sensor0.822.5011GXS700012016-09-24
EKAV082250120Gendex GXS-700™ intraoral sensor0.822.5012GXS700022016-09-24
EKAV082250130Gendex GXS-700™ intraoral sensor0.822.5013GXS700122016-09-24
EKAV082252120Gendex eXpert DC™ intraoral x-ray system0.822.5212EXPERTDC55 NA2016-09-27
EKAV082252140Gendex eXpert DC™ intraoral x-ray system0.822.5214EXPERTDC65 NA2016-09-27
EKAV100625810Gendex eXpert DC™ intraoral x-ray system1.006.2581EXPERTDC75 NA2016-09-27
EKAV100719700Gendex GXC-300™ intraoral camera1.007.1970120 0209G12016-09-24

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Primary DI, Brand, Company table
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08800011200084Dental Digital X-ray Imaging DevicePOINTIMPLANT Co., Ltd.MUH2026-05-21
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