OSUNG MND

OSUNG MND Co., Ltd. · Model SAE1 · UDI-DI 08800075614414

510(k) clearances

Adverse events

Recalls

Facilities

Description

A hand-held manual dental instrument consisting of a barrel (cylinder) with plunger/piston intended to be used to inject an anaesthetic agent under pressure via the periodontal ligament or into bone through an attached sterile needle. This is a reusable device.

Recalls

Date	Firm	Reason
2015-02-11	Milestone Scientific, Inc.	Wand Handpiece was mislabeled as STA handpiece. The Wand handpiece cannot be installed in the STA instrument.

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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.