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X-CUBE

Saeshin Precision Co., Ltd. · Model ACL-02C · UDI-DI 08809260470330

EGS
1
510(k) clearances
2,629
Adverse events
2
Recalls
91
Facilities

Description

Angle Handpiece

Recalls

DateFirmReason
2023-10-06Young Dental Manufacturing I, LLCone lot of Contra Gray (soft) Turbo Plus Cups Dental Prophylaxis Angles may contain Contra Petite Web LF Soft Purple Cup DPAs.
2015-08-27Bien Air Dental SAPossible loosening of the dental tool, which may lead to potential swallowing of the tool.

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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.