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ever GUIDE KIT

Shinhung MST Co., Ltd. · Model GLD2608 · UDI-DI 08806343924070

DZA Prescription

510(k) clearances

599

Adverse events

Recalls

192

Facilities

Description

A dental implant surgical drill used to install dental implant fixtures. It is used to correct drill path deviation and form the implantation path and depth according to the fixture length in extraction cases.

Recalls

Date	Firm	Reason
2025-04-14	Straumann USA LLC	The referred batch was produced without the laser engraving of 7 mm.
2017-07-10	Zimmer Dental Inc	Zimmer Biomet is conducting a medical device field correction for various dental products due to several parts being shipped to the customer with only standard IFUs. All the produc
2009-06-29	Biomet 3i, LLC	Some of the packages of ACT3020, drills may actually contain an ACT3220 drill.

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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.