DENTRIα Series
The DENTRIα series provides X-ray imaging for dental diagnosis, orthodontics and examination of the head and neck, including ear, nose and throat regions. It supports adult and pediatric…
The DENTRIα series provides X-ray imaging for dental diagnosis, orthodontics and examination of the head and neck, including ear, nose and throat regions. It supports adult and pediatric dentistry and is operated by physicians, dentists or X-ray technologists. The series produces panoramic images and three dimensional computed tomography images.
During a CT scan, the X-ray source and detector rotate around the patient, recording projections from different angles. Software reconstructs these measurements into tomographic images for viewing and analysis of anatomical structures. A positioning laser helps align the patient before the exposure.
Listed Item
The DENTRIα series 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 DENTRIα series 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 DENTRIα series used by physicians, dentists, and x-ray technologists.
Imaging Configurations
DENTRIα combines CT and panoramic modes. DENTRI-Cα adds single exposure cephalometric imaging, while DENTRI-Sα adds scanning cephalometric imaging. Image data are sent to the workstation through wired Ethernet and RS232 connections.
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) | K160140 |
| Record published | 2016-12-25 |
| Record revised | 2022-01-06 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Handling environment humidity 20 to 75 % RH; Handling environment temperature 10 to 40 °C; Storage environment humidity 5 to 95 % RH; Storage environment temperature 0 to 40 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DENTRI-Cα | In distribution | |
| DENTRIα | In distribution | |
| DENTRI-Cα | In distribution | |
| DENTRI-Sα | In distribution | |
| DENTRIα | In distribution | |
| DENTRI-Sα | 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.