Bright CT

This product is a dental computed tomography device designed to obtain images of the patient's teeth, nasal cavity, and jaw joint by placing X-rays and image detection sensors facing each…

Registry build 21.09.26

This product is a dental computed tomography device designed to obtain images of the patient’s teeth, nasal cavity, and jaw joint by placing X-rays and image detection sensors facing each other to obtain images while rotating around the patient’s central axis, and to analyze while displaying tomography images of the patient’s interest on the screen through computer calculation. In addition, this product includes functions such as reconstructing images and displaying images, modifying images, and storing images as an image manipulation function. It is equipped with a CT (Computational tomography) mode that can acquire a three-dimensional tomography image and a Panoramic mode for acquiring a two-dimensional semi-elliptical flat image, and includes a Cephalo mode used for rear and lateral head photography with a Scan method as an optional specification.

4manufacturers in China registered for this device type
6catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (2), Guangdong (1), Zhejiang (1).

Chinese manufacturers registered for FDA product code OAS
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

Regulatory record for bright CT
Listed by Dentium Co., Ltd., South Korea
FDA product code OAS
Device type X-Ray, Tomography, Computed, Dental
Device class Class 2
Regulation 21 CFR 892.1750
Establishment Manufacturer
510(k) K231181
Record published 2023-12-26

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Label carries lot or batch number, manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for bright CT
Catalogue number Size Status
ICT-R02-2TC In distribution
ICT-R02-1T In distribution
ICT-R02-2TS In distribution
ICT-R02-2T In distribution
ICT-R02-1TC In distribution
ICT-R02-2TSC In distribution

Same Product Code

Other products under the same FDA 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

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer