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Universal Shapers
UNIVERSAL SHAPERS LLC · Model Cortical Release Drill CR 4.2mm X 5mm · UDI-DI 00860014936616
10
510(k) clearances
599
Adverse events
3
Recalls
190
Facilities
Description
A specialized surgical instrument used in dentistry, particularly during implant placement or guided bone regeneration, to precisely perforate or remove the dense outer layer of cortical bone.
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.