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NewTom

CEFLA SOCIETA' COOPERATIVA · Model NewTom GO (3D) · UDI-DI 08033837931461

OASMUH Prescription
1
510(k) clearances
7
Adverse events
7
Recalls
48
Facilities

Description

Extraoral X­ray system for digital X­rays imaging suitable for: - production of orthopanoramic images of the maxillofacial region, diagnostic examination of the dentition (teeth), arches and other structures of the oral cavity - produce tomographic images of the oral cavity and maxillofacial structures and carry out diagnostic examination on teeth, dental arches, stmctures of the oral cavity and some cranial bones

Recalls

DateFirmReason
2025-08-26OSSTEM 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
2025-08-26OSSTEM 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
2025-08-26OSSTEM 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
2021-10-28Palodex Group OyIt 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
2021-07-21Trophy SASDevice failed to function as intended and/or failed to conform to their design specifications.
2018-12-31KaVo Dental Technologies LLCORTHOPANTOMOGRAPH OP 3D device has a defect in the device firmware versions 2.1.0 and 2.1.1
2015-08-05Villa Radiology Systems LLCIt 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.