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OPERA SYSTEM®
Shining 3D Tech Co., Ltd. · Model OS GOLDY · UDI-DI 06970163082103
5
510(k) clearances
36
Adverse events
1
Recalls
148
Facilities
Description
The scanner is used to scan and capture the 3D characteristics of dental models including plaster models and impressions. It can work with the supplied software to export the 3D scan data for CAD/CAM. the scan data can be apply for the orthodontic, restoration and implant.
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.