EzDent-i

Primary DI
08800019700197
Brand
EzDent-i
Company
EWOO SOFT Co., Ltd
Model
v3.1
Device description
EzDent-i is dental imaging software that is intended to provide diagnostic tools for maxillofacial radiographic imaging. These tools are available to view and interpret a series of DICOM compliant dental radiology images and are meant to be used by trained medical professionals such as radiologist and dentist. EzDent-i is intended for use as software to acquire, view, save 2D image files, and load DICOM project files from panorama, cephalometric, and intra-oral imaging equipment.
Published
2020-09-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K202116000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202116000EzDent-i/ E2/ Prora View/ Smart M ViewerEwoosoft Co., Ltd.2020-08-21LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800019700197PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800019700197088000197001978800019700197

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose dental x-ray system application softwareAn individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to a general-purpose dental x-ray system configuration. A basic set of applications programs and routines are included with such computer-controlled imaging systems and they can be upgraded to correct programming errors or to add new system capabilities. Some application software routines or groups of routines (packages) must be combined with specific hardware or firmware configurations in order to function as intended. Applications program packages are typically identified by a proprietary name and "version" or "upgrade" number.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
688379797
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800019700593Clever One1.02025-05-28
08800019700531EzDent-i3.52024-08-13
08800019700401Ez3D-i5.52023-07-26
08800019700395EzDent Webv1.22023-07-14
08800019700388EzDent-i3.42023-03-07
08800019700319EzOrtho1.32022-10-13
08800019700340Ez3D-i5.42022-10-13
08800019700357EzDent-i3.32022-10-13
08800019700227EzDent-iv3.22021-11-08
08800019700234Ez3D-iv5.32021-11-08
08800019700241EzDent Webv1.02021-11-08
08800019700258EzOrtho1.22021-11-08
08800019700081OrthoVisionv2.12020-12-15
08800019700159EzOrtho1.02020-11-25
08800019700173Ez3D-iv5.22020-11-25
08800019700203EzOrtho1.12020-11-25
08800019700180Smart M Viewerv3.02020-05-07
08800019700142EzMobilev1.12020-02-05
08800019700128Ez3D-iv5.12019-05-31
08800019700111EzDent-iv3.02019-05-20

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