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Surgical Kit
Shinhung MST Co., Ltd. · Model SBPN50 · UDI-DI 08809458319953
DZA
Prescription
10
510(k) clearances
599
Adverse events
3
Recalls
190
Facilities
Description
These Drills are surgical tools that are used to expect the direction and place of implant, to measure the drilling hole depth and gingival height for selecting abutments according to gingival heights and to insert the implant in prepared implant site after drilling for preparation of the site of dental implants, to successful Crestal Approach Sinus operation by cutting sinus floor promptly and lifting up the Sinus Membrane safely.
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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Get your free API keyRead the docsData 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.