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iRay Group · Model iScan · UDI-DI 06970569090993
NOF
Prescription
5
510(k) clearances
36
Adverse events
1
Recalls
148
Facilities
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.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-02-15 | CARESTREAM DENTAL, LLC | The mirror may become detached and fall from the unit |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.