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OSUNG MND
OSUNG MND Co., Ltd. · Model RDC210 · UDI-DI 08800075603418
3
510(k) clearances
301
Adverse events
1
Recalls
98
Facilities
Description
A dental device with a buccal and lingual wing, or flange, used to anchor a rubber dam down to the cervical region of an exposed tooth. This device comes in a variety of shapes, sizes, and designs for various situations. It is typically made of spring metal and has bevelled jaws that contact the tooth, and a bow that connects the jaws. This is a reusable device.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-04-21 | Dentech Corp. | Removing parts for safety reasons due to possible breakage. |
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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.