NewTom

Basic Information

• Brand Name: NewTom
• Primary DI: 08033837938286
• Version / Model: VisioScan WR
• Catalog Number: 7098N001
• Company Name: CEFLA SOCIETA' COOPERATIVA
• Labeler DUNS: 429341410
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-01-01
• Public Version: 1
• Public Version Date: 2025-01-09
• Public Version Status: New
• Public Device Record Key: 9656ccd7-5b2e-444f-bdb7-26234c8c9730

Device 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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NOF	System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations	Dental	872.3661	2

GMDN Terms

Code	Name	Definition	Implantable	Status
63669	Intraoral optical scanning system	An assembly of electronic devices intended to use optical technology to capture digital topographical 3-D images of teeth, oral cavity structure and geometry, and bite relationship of a patient; it is typically in addition capable of detecting dental caries. It consists of a hand-held intraoral scanner with near infrared (NIR) and laser illumination, and a mobile unit with a user interface with display/controls. The resulting digital dental impressions may be used for CAD/CAM fabrication of dental restorations and orthodontic devices.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08033837938286	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 10 – 95 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -10 – 50 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 10 – 65 Percent (%) Relative Humidity