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OSUNG MND

OSUNG MND Co., Ltd. · Model 3ORWBP1 · UDI-DI 08800075622747

ECS
2
510(k) clearances
2
Adverse events
0
Recalls
105
Facilities

Description

A hand-held device intended to be used by laypersons to remove/apply orthodontic elastomeric appliances (e.g., inter-arch bands, inter-bracket chains) from/to orthodontic brackets. It is typically a thin plastic device with a hook on one end and a pusher on the other, intended to be used by a patient in the home (e.g., before and after eating or sleep). This is a single-use device.

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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.