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OSUNG MND

OSUNG MND Co., Ltd. · Model BOC35 · UDI-DI 08800075612397

EMM

510(k) clearances

Adverse events

Recalls

132

Facilities

Description

A hand-held, dental, surgical instrument used during dental osteotomy for shaping and condensing bone, typically when performing a dental implant surgical procedure. It is hand-held by the dentist who will use a surgical mallet or hammer to manually impart an impacting force to the proximal end of the instrument. The device will have a straight or bayonet-shaped handle leading to a round or concave tip at the distal end, which may be marked with graduations to indicate depth differences. It is used for ridge expanding, bone condensing and sinus floor elevation procedures. This device will be made of high-grade stainless steel. This is a reusable device.

Recalls

Date	Firm	Reason
2008-04-16	Biomet Microfixation, Inc.	The working tips of the Stella Osteotomes are thicker than specification.

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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.