MOBILE-X

GUDID 00858475006153

The device is a diagnostic X-ray system, which is intended to be used by trained dentists and dental X-ray source for producing diagnostic X-ray images using intra-oral image receptors Its use is in adults and pediatric subjects.

DENTERPRISE INTERNATIONAL, INC.

Hand-held intraoral dental x-ray system, digital

• Primary Device ID: 00858475006153
• NIH Device Record Key: eb3aa1f6-1599-4da2-9229-cb120b8008de
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MOBILE-X
• Version Model Number: T100
• Company DUNS: 024913248
• Company Name: DENTERPRISE INTERNATIONAL, INC.
• 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: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8003232690
• Email: info@denterpriseint.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858475006153 [Primary]

FDA Product Code

• EHD: Unit, X-Ray, Extraoral With Timer

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: 2018-06-29
• Device Publish Date: 2018-05-29

Devices Manufactured by DENTERPRISE INTERNATIONAL, INC.

• 00858475006337 - Smil-O-Ray: 2024-01-15 Portable X-ray System
• 00858475006269 - QuickRay DX Size 1: 2023-08-02
• 00858475006276 - QuickRay DX Size 2: 2023-08-02
• 00858475006115 - iCam: 2022-02-11 Intraoral Camera
• 00858475006177 - InstaRay: 2019-08-01
• 00858475006184 - InstaRay: 2019-08-01 Indications for Use: Radiographic examination and diagnosis of diseases of the teeth, jaw and oral structure.
• 00858475006009 - Xray2Go: 2018-07-06 Indications for Use: The Portable X-ray system (Model: EXARO, Xray2GO) is intended to be used by trained dentists and dental tec
• 00858475006016 - QuickRay HD #2: 2018-07-06 Indications for Use: Radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structure.