Dentri Max
The DENTRI dental X-ray system produces three-dimensional tomographic images and panoramic images for dental assessment. Its X-ray source and detector rotate around the patient, collecting…
The DENTRI dental X-ray system produces three-dimensional tomographic images and panoramic images for dental assessment. Its X-ray source and detector rotate around the patient, collecting views from different angles that software reconstructs into images of the head and neck.
The listed DENTRIα, DENTRI-Cα and DENTRI-Sα models share CT and panoramic imaging. DENTRI-Cα adds one-shot cephalometric imaging, while DENTRI-Sα adds scanning cephalometric imaging. Model scanning is available as an option.
Listed Item
The DENTRI Max is a Computed Tomography X-Ray imaging device specialized in diagnosing general dental treatments and orthodontic purpose using Panoramic and Cephalometric images respectively. In addition DENTRI Max is used in the field of Otolaryngology by capturing 360 degree rotation sequence of the head and neck areas, including the ENT and dentomaxillofacial areas for a dental treatment in adult and pediatric dentistry and obtains x-ray images from different angles and calculate through computer-processed to produce 3D x-ray tomographic images. The DENTRI Max used by physicians, dentists, and x-ray technologists.
Intended Examinations
The system is used by physicians, dentists and X-ray technologists in adult and pediatric dentistry. Its applications include general dental assessment, orthodontic imaging and examination of ear, nose, throat and dentomaxillofacial areas.
Who Else Makes It
Concentrated in Jiangsu (2), Guangdong (1), Zhejiang (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Changzhou Sifary Medical Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 14 |
| Fussen Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 3 |
| Yian Medical Technology (Haining) Co., Ltd. | Jiaxing | Zhejiang | Specification developer | 1 |
| Changzhou Finno Medical Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 1 |
Record
| Listed by | HDX Will Corp., South Korea |
|---|---|
| FDA product code | OAS |
| Device type | X-Ray, Tomography, Computed, Dental |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1750 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K212254 |
| Record published | 2022-04-29 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DENTRI-Sα | In distribution | |
| DENTRI-Cα | In distribution | |
| DENTRIα | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Rayscan | RAY Co., Ltd., | 52 |
| Rayscan Studio | RAY Co., Ltd., | 21 |
| Dental CT Scanner AXR | Alliage S/A Indústrias Médico Odontológica | 15 |
| PaX-i3D Green | Vatech Co., Ltd. | 14 |
| Orthopantomograph™ OP 3D | Palodex Group OY | 11 |
| Sleeve for extraoral X-Ray devices | Sirona Dental Systems Gmbh | 11 |
| SXR / Saevo | Alliage S/A Indústrias Médico Odontológica | 11 |
| X-Mind trium | DE Götzen SRL | 10 |
| Genoray | Genoray Co., Ltd. | 9 |
| Rayscan α-Expert3D | RAY Co., Ltd., | 9 |
| Orthophos SL | Sirona Dental Systems Gmbh | 9 |
| Orthophos XG | Sirona Dental Systems Gmbh | 9 |
Showing 12 of 110. All products under X-Ray, Tomography, Computed, Dental
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K211159 | 2021-12-30 |
| K212254 | 2021-10-19 |
| K160140 | 2016-09-30 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.