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Universal Shapers
UNIVERSAL SHAPERS LLC · Model Scalloping Drill SS5 · UDI-DI 00860014936623
10
510(k) clearances
599
Adverse events
3
Recalls
190
Facilities
Description
A specialized dental instrument used for bone profiling, shaping, and sculpting in implant dentistry. These drills are designed to create a "scalloped" or contoured bone profile around the platform of dental implants to better match the natural, anatomical shape of the bone, particularly in the esthetic zone (anterior maxilla).
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.