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IMPRESS

Wuxi EA Medical Instruments Technologies Limited. · Model EAB II · UDI-DI 06956748701614

NXC Prescription

510(k) clearances

18,531

Adverse events (1 deaths)

Recalls

Facilities

Recalls

Date	Firm	Reason
2024-11-22	3M Company - Health Care Business	Attachments may not mate with the tooth as intended in the digital treatment design.
2024-11-04	Straight Smile, LLC	Virtual-only clinical workflow utilized for dental aligners and impression to approve patients for aligner devices may not be suitable for patients who have certain contraindicatio

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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.