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Adite®

Shining 3D Tech Co., Ltd. · Model A-IS Pro3 · UDI-DI 06970163081885

NOF
5
510(k) clearances
36
Adverse events
1
Recalls
149
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

DateFirmReason
2021-02-15CARESTREAM DENTAL, LLCThe mirror may become detached and fall from the unit

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Data 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.