bright CT

Dentium Co., Ltd · Model ICT-R02-2TSC · UDI-DI 08809772430617

510(k) clearances

Adverse events

Recalls

Facilities

Description

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.

Recalls

Date	Firm	Reason
2025-08-26	OSSTEM Implant Co., Ltd.	Osstem Implant Co. Ltd, is voluntarily initiating a medical device correction involving the current labeling for this electronic product may be missing a required Certification Sta
2025-08-26	OSSTEM Implant Co., Ltd.	Osstem Implant Co. Ltd, is voluntarily initiating a medical device correction involving the current labeling for this electronic product may be missing a required Certification Sta
2025-08-26	OSSTEM Implant Co., Ltd.	Osstem Implant Co. Ltd, is voluntarily initiating a medical device correction involving the current labeling for this electronic product may be missing a required Certification Sta
2021-10-28	Palodex Group Oy	It was noticed in production on 28.10.2021, that the final testing database gives a pass result for Pan ADC repeatability test even when the test result is not within the set accep
2021-07-21	Trophy SAS	Device failed to function as intended and/or failed to conform to their design specifications.
2018-12-31	KaVo Dental Technologies LLC	ORTHOPANTOMOGRAPH OP 3D device has a defect in the device firmware versions 2.1.0 and 2.1.1
2015-08-05	Villa Radiology Systems LLC	It has been discovered that due to lack of information accompanying documents the product fails to comply with 21CfR 1020.33(c),1020.33(d),1020.33(g),and 1020.330).

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.