WebCeph

Primary DI
08800183400008
Brand
WebCeph
Company
AssembleCircle
Model
V1.0.0
Device description
WebCeph is a 2D orthodontic analysis program. It manages patient information and images for orthodontic analysis. This software also assists in orthodontic treatment by providing accurate image analysis, superimpositions, and VTO (visualized treatment objective) and STO (surgical treatment objective). The analyzed results are saved in chart format so that the users can easily store and track the treatment and records of each patient. This device is designed to provide a simple and straightforward user interface.WebCeph is used for registering orthodontic medical images and managing patient information through the features of making schedules and managing patient appointments. This software receives image files (JPG, BMP, PNG) as input sources and enables the users to easily calibrate the size of the image or arrange multiple film/photo images.
Published
2022-11-06
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
K220903000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220903000WebCephAssemblecircle Corp.2022-08-17LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800183400008PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800183400008088001834000088800183400008

GMDN Terms#

Term, Definition table
TermDefinition
Dental treatment application softwareAn application software program intended to facilitate dental treatment, which may include dental implant and/or oral/maxillofacial surgery planning, by storing/displaying patient demographics/clinical data and treatment plans, and may control settings for dental equipment (e.g., a line-powered dental drilling system). It is typically for installation in an off-the-shelf desktop, laptop or tablet computer, which may require a connection to the dental equipment. It typically includes upgrades to the software.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
695644990
Device count
1

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00817886020554JointsMEDSTRAT, INC.LLZ2023-11-13
00350227000520EaglesoftPATTERSON TECHNOLOGY CENTERLLZ2023-10-25
00754016387111ANDIImeka Solutions IncLLZ2023-09-01
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00817886020509JointsMEDSTRAT, INC.LLZ2023-04-03
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00195278517340ViewPointGE Healthcare GmbHLLZ2023-02-15
00817886020486JointsMEDSTRAT, INC.LLZ2023-01-20
00670082000511Modus PlanSynaptive Medical IncLLZ2022-12-13
00817886020479JointsMEDSTRAT, INC.LLZ2022-10-29
00817886020462JointsMEDSTRAT, INC.LLZ2022-09-05
00817886020455JointsMEDSTRAT, INC.LLZ2022-08-01