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OSUNG MND
OSUNG MND Co., Ltd. · Model PSM019F · UDI-DI 08800075628985
10
510(k) clearances
523
Adverse events
13
Recalls
267
Facilities
Description
A rotary cutting device made of high-grade steel with the working end coated with particles of diamond, and which is designed to fit into a dental handpiece that provides the rotation allowing the user to cut hard structures in the mouth, such as teeth or bone. It can also be used to cut hard metals, plastics, porcelains and similar materials intended for use in the fabrication of dental devices. It is available in various shapes (e.g., cylinder, disk, sphere, oval). This is a single-use device.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-02-27 | Premier Dental Products Co | The hardness not meeting the material specification and may cause the diamond bur to bend. |
| 2024-01-11 | Brasseler USA I Lp | The device has a grip detail (right angle latch) out of specification causing the bur to not adequately latch in the handpiece. |
| 2020-10-20 | Coltene Whaledent Inc | The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the FG 57 burs. |
| 2020-10-20 | Coltene Whaledent Inc | The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the FG 57 burs. |
| 2020-10-20 | Coltene Whaledent Inc | The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the FG 57 burs. |
| 2020-10-20 | Coltene Whaledent Inc | The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the FG 57 burs. |
| 2020-10-20 | Coltene Whaledent Inc | The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the FG 57 burs. |
| 2020-07-15 | Hager & Meisinger Gmbh | US-dates between the product package label and the bar code display. |
| 2019-12-23 | Jjgc Industria E Comercio De Materials Dentarios Sa | The laser engraving of the product incorrectly identifies the 4.3 Tapered Guided Surgery Drill as the "4.3+ Tapered Guided Surgery Drill". |
| 2019-07-19 | Coltene /Whaledent AG | A single batch of Diatech Diamond dental burs, 856-016-7-F, Round end taper, contain diamond burs with the same grit size (fine) and shape (round end taper) but different length. |
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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.