WebCeph

GUDID 08800183400008

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.

AssembleCircle

Dental treatment application software

• Primary Device ID: 08800183400008
• NIH Device Record Key: 2dfda910-9f2f-47f4-bb51-3978d0eb2335
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WebCeph
• Version Model Number: V1.0.0
• Company DUNS: 695644990
• Company Name: AssembleCircle
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800183400008 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220903

FDA Product Code

• LLZ: System, Image Processing, Radiological

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-11-14
• Device Publish Date: 2022-11-06