FDA.reportPublic FDA data

Gendex GXC-300™ intraoral camera

Primary DI
EKAV100719700
Brand
Gendex GXC-300™ intraoral camera
Company
GENDEX CORP.
Model
1.007.1970
Catalog number
120 0209G1
Device description
Digital intraoral cameraDigital intraoral camera
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
EIAUNIT, OPERATIVE DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIAUnit, Operative DentalDental1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K040691000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K040691000INTRA ORAL CAMERA SYSTEM & ACCESSORIES, MODEL WIN-100DWin-Us Technology Co., Ltd.2004-03-23EIA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EKAV100719700PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Multi-purpose digital medical cameraA battery-powered hand-held digital electro-optical device designed to capture video or still image data for a variety of medical applications (e.g., ophthalmoscopic, otoscopic and dermatoscopic) using dedicated interchangeable lenses. It typically consists of a lightproof chamber with an aperture fitted with a lens and a shutter, through which the image of an object is projected onto a surface for recording. It typically has a user display screen for visualization before image capture, and a docking cradle for battery recharging and connection to a personal computer.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
144575763
Device count
1
Serial number
true
Manufacturing date on label
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
EKAV100762000Gendex GXS-700™ intraoral sensor1.007.6200GXS70001S2016-09-24

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