NewTom 70EF0000

GUDID 08033837936107

Panoramic, cephalometric and tomographic X-ray equipment

CEFLA SOCIETA' COOPERATIVA

Stationary panoramic/tomographic dental x-ray system, digital

• Primary Device ID: 08033837936107
• NIH Device Record Key: 7f367b58-7f4d-4060-af06-3f52ddd7f25a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NewTom
• Version Model Number: NewTom VG-One (3D)
• Catalog Number: 70EF0000
• Company DUNS: 429341410
• Company Name: CEFLA SOCIETA' COOPERATIVA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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

Operating and Storage Conditions

• Handling Environment Atmospheric Pressure: Between 71 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 71 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 71 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 71 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 71 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 71 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	08033837936107 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K252353

FDA Product Code

• OAS: X-Ray, Tomography, Computed, Dental

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-03-23
• Device Publish Date: 2026-03-13