OSUNG MND

OSUNG MND Co., Ltd. · Model TITU5 · UDI-DI 08800075605474

510(k) clearances

Adverse events

Recalls

Facilities

Description

A hand-held dental instrument used to excise the gums and other oral soft tissue during a periodontal intervention (e.g., a gingivectomy involving the excising of the soft tissue wall of a pocket). It is typically designed as a one-piece instrument with a sharp, single-edged cutting blade of various shapes and sizes along the working end. It can be a single-ended or double-ended instrument with a handle at the proximal end or positioned centrally. It is usually made of high-grade stainless steel. This is a reusable device.

Recalls

Date	Firm	Reason
2018-03-28	Ace Surgical Supply Co., Inc.	The product inside the package is incorrect. A single blade shoe was mistakenly packaged instead of a double blade.

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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.