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Surgical Kit

Shinhung MST Co., Ltd. · Model TWMA00L · UDI-DI 08806343902467

EJB Prescription

510(k) clearances

Adverse events

Recalls

267

Facilities

Description

These instruments are surgical tools that are used to expect the direction and place of implant, to measure the drilling hole depth and gingival height for selecting abutments according to gingival heights and to insert the implant in prepared implant site after drilling for preparation of the site of dental implants, to successful Crestal Approach Sinus operation by cutting sinus floor promptly and lifting up the Sinus Membrane safely.

Recalls

Date	Firm	Reason
2008-05-09	Biomet 3i, Inc.	The drill malfunctions while in use. The drill has been observed to become lodged in the handle.

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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.