DENTRIα series

HDX WILL CORP. · Model DENTRIα · UDI-DI 08800005200380

OAS Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

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.

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.