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Dental Surgical Drill

Cowellmedi Co.,Ltd · Model 2KTD3012 · UDI-DI 08800016167627

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.

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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.