gudid Primary ID: VisioScan WL

NewTom (UDI VisioScan WL)

Manufactured by CEFLA SOCIETA' COOPERATIVA

Data verified against official FDA/EUDAMED records on August 9, 2026

Scannable UDI-DI Representation

Device Regulatory Overview

The NewTom (Model/Catalog Number: VisioScan WL) is a medical device manufactured by CEFLA SOCIETA' COOPERATIVA. This product is indexed under FDA Product Code / Category Classification NOF within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: VisioScan WL
Product Code / EMDN: NOF
Device Name: 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.
Database Sync Date: 2026-08-09 09:04:34

Full Regulatory Attributes

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{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}

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Frequently Asked Questions

Who is the primary manufacturer of NewTom?

The registered manufacturer of record for NewTom is CEFLA SOCIETA' COOPERATIVA.

What is the Primary UDI-DI identifier for NewTom?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is VisioScan WL.

What classification code is assigned to this device?

This device is registered under product classification code NOF.

Similar Classification Devices (NOF)

Other Devices by CEFLA SOCIETA' COOPERATIVA

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