iRay

GUDID 06970569090993

The iScan system is an intraoral scanner that uses the optical scanning method to obtain the three-dimensional shape feature data of the surfaces of teeth, gums, and other tissues. It outputs the three-dimensional digital impression data. This device is intended for use in medical institutions, providing 3D scanning for adult and pediatric patients undergoing dental treatments like restorations, orthodontics, and implants.

iRay Group

Intraoral optical scanning system

• Primary Device ID: 06970569090993
• NIH Device Record Key: 18f10166-2d56-4016-a2be-01af7d447f6b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iRay
• Version Model Number: iScan
• Company DUNS: 421363780
• Company Name: iRay Group
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	06970569090993 [Primary]

FDA Product Code

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

Sterilization

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

[06970569090993]

Moist Heat or Steam Sterilization;High-level Disinfectant

[06970569090993]

Moist Heat or Steam Sterilization;High-level Disinfectant

[06970569090993]

Moist Heat or Steam Sterilization;High-level Disinfectant

[06970569090993]

Moist Heat or Steam Sterilization;High-level Disinfectant

[06970569090993]

Moist Heat or Steam Sterilization;High-level Disinfectant

[06970569090993]

Moist Heat or Steam Sterilization;High-level Disinfectant

[06970569090993]

Moist Heat or Steam Sterilization;High-level Disinfectant

[06970569090993]

Moist Heat or Steam Sterilization;High-level Disinfectant

[06970569090993]

Moist Heat or Steam Sterilization;High-level Disinfectant

[06970569090993]

Moist Heat or Steam Sterilization;High-level Disinfectant

[06970569090993]

Moist Heat or Steam Sterilization;High-level Disinfectant

[06970569090993]

Moist Heat or Steam Sterilization;High-level Disinfectant

[06970569090993]

Moist Heat or Steam Sterilization;High-level Disinfectant

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-01-21
• Device Publish Date: 2026-01-13

Devices Manufactured by iRay Group

• 06970569090993 - iRay: 2026-01-21The iScan system is an intraoral scanner that uses the optical scanning method to obtain the three-dimensional shape feature data of the surfaces of teeth, gums, and other tissues. It outputs the three-dimensional digital impression data. This device is intended for use in medical institutions, providing 3D scanning for adult and pediatric patients undergoing dental treatments like restorations, orthodontics, and implants.
• 06970569090993 - iRay: 2026-01-21 The iScan system is an intraoral scanner that uses the optical scanning method to obtain the three-dimensional shape feature dat
• 06970569090856 - Digital Intraoral X-ray Imaging System: 2025-09-08 The Digital Intra-Oral X-Ray Imaging System is used in conjunction with dental Radiography in medical units. The product is used
• 06970569090863 - Digital Intraoral X-ray Imaging System: 2025-09-08 The Digital Intra-Oral X-Ray Imaging System is used in conjunction with dental Radiography in medical units. The product is used
• 06970569091006 - Digital Radiographic Imaging Acquisition Software - DR (RiasDR): 2025-09-03 Digital Radiographic Imaging Acquisition Software - DR (RiasDR)
• 06970569091020 - Wireless Digital Flat Panel Detector: 2025-06-19 DR10FW Wireless Digital Flat Panel Detector_LTF
• 06970569090931 - Mano4336A Wireless Digital Flat Panel Detector: 2025-05-21 Mano4336A clearance depends on Mars1417X by LTF
• 06970569090948 - Mano4336F Wireless Digital Flat Panel Detector: 2025-05-21 Mano4336F clearance depends on Mars1417X by LTF
• 06970569090955 - Mano4343A Wireless Digital Flat Panel Detector: 2025-05-21 Mano4336A clearance depends on Mars1717X by LTF