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OSUNG MND
OSUNG MND Co., Ltd. · Model 2MHC3 · UDI-DI 08800075627247
8
510(k) clearances
39
Adverse events
1
Recalls
267
Facilities
Description
A hand-held, manual device designed to hold and facilitate manipulation of a non-powered, non-rotary dental instrument (e.g., endodontic file/rasp, implant extractor). It is designed to accept the patient-contact endpiece (not included) for ease of handling. This is a reusable device.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2008-05-09 | Biomet 3i, Inc. | The drill malfunctions while in use. The drill has been observed to become lodged in the handle. |
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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.