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S-Guide Kit

Shinhung MST Co., Ltd. · Model CDW · UDI-DI 08806343921185

DZA Prescription

510(k) clearances

599

Adverse events

Recalls

190

Facilities

Description

Keyless, precise, open-guided surgery kit, designed to allow for more accurate, efficient, and safe surgery with minimal error and drill heating.

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.