FDA Device Intelligence
HomeOsstem Implant Co., Ltd. › OneGuide Path Drill

OneGuide Path Drill

Osstem Implant Co., Ltd. · Model OGSD3007 · UDI-DI 08809917099006

DZA Prescription
10
510(k) clearances
599
Adverse events
3
Recalls
190
Facilities

Recalls

DateFirmReason
2025-04-14Straumann USA LLCThe referred batch was produced without the laser engraving of 7 mm.
2017-07-10Zimmer Dental IncZimmer 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
2009-06-29Biomet 3i, LLCSome of the packages of ACT3020, drills may actually contain an ACT3220 drill.

Query this across every FDA database — by API.

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

Get your free API keyRead the docs
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.