WebCeph
Basic Information
- Brand Name
- WebCeph
- Primary DI
- 08800183400008
- Version / Model
- V1.0.0
- Company Name
- AssembleCircle
- Labeler DUNS
- 695644990
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-06
- Public Version
- 1
- Public Version Date
- 2022-11-14
- Public Version Status
- New
- Public Device Record Key
- 2dfda910-9f2f-47f4-bb51-3978d0eb2335
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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LLZ | System, Image Processing, Radiological | Radiology | 892.2050 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60883 | Dental treatment application software | An 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08800183400008 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K220903 | 000 |