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OSUNG MND

OSUNG MND Co., Ltd. · Model SAA1 · UDI-DI 08800075614360

EJI
10
510(k) clearances
34
Adverse events
1
Recalls
78
Facilities

Description

A hand-held manual dental instrument consisting of a barrel (cylinder) with plunger/piston intended to be used for injecting an anaesthetic agent, subcutaneously or intramuscularly, from a prefilled, single-use cartridge through an attached sterile needle; a needle is not included. This is a reusable device.

Recalls

DateFirmReason
2015-02-11Milestone 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.