FDA UDI
In Commercial Distribution
🇺🇸 United States
iRay
DI: 06970569090993
·
Model: iScan
·
iRay Group
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- iRay
- Primary DI
- 06970569090993
- Version / Model
- iScan
- Company Name
- iRay Group
- Labeler DUNS
- 421363780
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-01-13
- Public Version
- 1
- Public Version Date
- 2026-01-21
- Public Version Status
- New
- Public Device Record Key
- 18f10166-2d56-4016-a2be-01af7d447f6b
Device Description
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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization, High-level Disinfectant
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NOF | System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | Dental | 872.3661 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63669 | Intraoral optical scanning system | An assembly of electronic devices intended to use optical technology to capture digital topographical 3-D images of teeth, oral cavity structure and geometry, and bite relationship of a patient; it is typically in addition capable of detecting dental caries. It consists of a hand-held intraoral scanner with near infrared (NIR) and laser illumination, and a mobile unit with a user interface with display/controls. The resulting digital dental impressions may be used for CAD/CAM fabrication of dental restorations and orthodontic devices. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06970569090993 | GS1 |