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OSUNG MND
OSUNG MND Co., Ltd. · Model EXC18 · UDI-DI 08800075605252
2
510(k) clearances
7
Adverse events
8
Recalls
121
Facilities
Description
A hand-held manual dental instrument designed for cutting, scraping, and removing the carious dentine of a decayed tooth or other pathological bone tissue within the oral cavity. It is made of high-grade stainless steel typically designed as a double-ended instrument, having a central handle, with small, sharp, spoon-, scoop-, or spatula-shaped blades that have sharp cutting/gouging edges. This is a reusable device.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2008-11-14 | Sybron Dental Specialties | The tips of the Neos Vanadium Excavators may prematurely release from the handle during use, and if so, the tip may be accidentally swallowed. |
| 2008-11-14 | Sybron Dental Specialties | The tips of the Neos Vanadium Excavators may prematurely release from the handle during use, and if so, the tip may be accidentally swallowed. |
| 2008-11-14 | Sybron Dental Specialties | The tips of the Neos Vanadium Excavators may prematurely release from the handle during use, and if so, the tip may be accidentally swallowed. |
| 2008-11-14 | Sybron Dental Specialties | The tips of the Neos Vanadium Excavators may prematurely release from the handle during use, and if so, the tip may be accidentally swallowed. |
| 2008-11-14 | Sybron Dental Specialties | The tips of the Neos Vanadium Excavators may prematurely release from the handle during use, and if so, the tip may be accidentally swallowed. |
| 2008-11-14 | Sybron Dental Specialties | The tips of the Neos Vanadium Excavators may prematurely release from the handle during use, and if so, the tip may be accidentally swallowed. |
| 2008-11-14 | Sybron Dental Specialties | The tips of the Neos Vanadium Excavators may prematurely release from the handle during use, and if so, the tip may be accidentally swallowed. |
| 2008-11-14 | Sybron Dental Specialties | The tips of the Neos Vanadium Excavators may prematurely release from the handle during use, and if so, the tip may be accidentally swallowed. |
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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.