NewTom 7098N001

GUDID 08033837938286

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.

CEFLA SOCIETA' COOPERATIVA

Intraoral optical scanning system

Primary Device ID	08033837938286
NIH Device Record Key	9656ccd7-5b2e-444f-bdb7-26234c8c9730
Commercial Distribution Status	In Commercial Distribution
Brand Name	NewTom
Version Model Number	VisioScan WR
Catalog Number	7098N001
Company DUNS	429341410
Company Name	CEFLA SOCIETA' COOPERATIVA
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	+1 (704)598-0020
Email	service@cefladental.com
Phone	+1 (704)598-0020
Email	service@cefladental.com
Phone	+1 (704)598-0020
Email	service@cefladental.com
Phone	+1 (704)598-0020
Email	service@cefladental.com
Phone	+1 (704)598-0020
Email	service@cefladental.com
Phone	+1 (704)598-0020
Email	service@cefladental.com
Phone	+1 (704)598-0020
Email	service@cefladental.com
Phone	+1 (704)598-0020
Email	service@cefladental.com
Phone	+1 (704)598-0020
Email	service@cefladental.com
Phone	+1 (704)598-0020
Email	service@cefladental.com
Phone	+1 (704)598-0020
Email	service@cefladental.com
Phone	+1 (704)598-0020
Email	service@cefladental.com
Phone	+1 (704)598-0020
Email	service@cefladental.com

Operating and Storage Conditions

Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	08033837938286 [Primary]

FDA Product Code

NOF	System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations