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NewTom

CEFLA SOCIETA' COOPERATIVA · Model VisioScan WL · UDI-DI 08033837937142

NOF Prescription

510(k) clearances

Adverse events

Recalls

149

Facilities

Description

The intraoral scanner is a digital optical scanning device used to obtain digital impressions of hard and soft tissues such as teeth, gums, and mucous membrane by means of oral scanning, for oral restoration and orthodontic treatment of malocclusion. The device is an optical impression system used to record the topographical characteristics of teeth, dental impressions, or stone models for use in the computer-aided design (CAD) and computer-aided manufacturing (CAM) of dental restorative prosthetic devices.

Recalls

Date	Firm	Reason
2021-02-15	CARESTREAM DENTAL, LLC	The mirror may become detached and fall from the unit

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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.