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OSUNG MND
OSUNG MND Co., Ltd. · Model THB50 · UDI-DI 08800075624697
10
510(k) clearances
523
Adverse events
13
Recalls
267
Facilities
Description
An orthopaedic surgical blade designed to cut and remove circular sections of bone, typically for biopsy or percutaneous bone graft harvesting. It is typically a hollow cylinder with a circular, saw-like serrated working edge. It is an exchangeable device that may be attached to a manually-operated handle or to a powered rotary surgical handpiece. The device is typically made of high-grade stainless steel. This is a reusable 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.