QuickRay DX Size 1 02QDX20300

GUDID 00858475006269

DENTERPRISE INTERNATIONAL, INC.

Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral

• Primary Device ID: 00858475006269
• NIH Device Record Key: c820a4d8-09e8-4249-9601-b984384d05f1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QuickRay DX Size 1
• Version Model Number: 1
• Catalog Number: 02QDX20300
• Company DUNS: 024913248
• Company Name: DENTERPRISE INTERNATIONAL, INC.
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858475006269 [Primary]

FDA Product Code

• MUH: System, X-Ray, Extraoral Source, Digital

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: 2023-08-02
• Device Publish Date: 2023-07-25

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
• 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.