EzDent Web

Primary DI
08800019700395
Brand
EzDent Web
Company
EWOO SOFT Co., Ltd
Model
v1.2
Device description
EzDent Web is a dental imaging software that enables you to save, manage, view and process patients’ images. EzDent Web is equipped with management and processing system for various 2D and 3D images. In addition, EzDent Web provides media contents for patient consultation and user friendly instruction to assist your use of the software.EzDent Web provides you with the following functions using patient images in 2D and 3D.- Manage patient information- View patient images in 2D/3D using tools for image processing and view function.- Use high resolution 3D VR to view 3D images in the optimized view for user intent.- Consult patients using media contents provided for patient consultation.
Published
2023-07-14
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
K230468000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230468000EzDent WebEwoosoft Co., Ltd.2023-04-21LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800019700395PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800019700395088000197003958800019700395

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
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
08800019700197EzDent-iv3.12020-09-14
08800019700180Smart M Viewerv3.02020-05-07
08800019700142EzMobilev1.12020-02-05
08800019700128Ez3D-iv5.12019-05-31
08800019700111EzDent-iv3.02019-05-20

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