OSUNG MND

OSUNG MND Co., Ltd. · Model GCP113 · UDI-DI 08800075609656

510(k) clearances

Adverse events

Recalls

Facilities

Description

A hand-held manual dental instrument designed specifically to pack a gingival retraction cord between the tooth and the gingiva during abutment preparation. It is a metallic single- or double-ended device with a spatula-like tip(s) which may have serrated edges. This is a reusable 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.