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ever GUIDE KIT

Shinhung MST Co., Ltd. · Model GFDTWR · UDI-DI 08806343924360

EJB Prescription
8
510(k) clearances
39
Adverse events
1
Recalls
272
Facilities

Description

This product is a dental implant screwdriver used to tighten or loosen fixtures, abutments, and screws during dental implant surgery. It is attached to a torque wrench and used when installing dental implant fixtures.

Recalls

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

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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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.