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OSUNG MND
OSUNG MND Co., Ltd. · Model RDSET · UDI-DI 08800075621320
3
510(k) clearances
301
Adverse events
1
Recalls
98
Facilities
Description
A collection of devices used to apply and remove a rubber dam, which is created chairside and placed over the crown of a patient's tooth or teeth in order to eliminate saliva or to prevent the patient swallowing liquid/dental material during dental surgery. It typically consists of rubber dam material, clamps, forceps, punch, frame, and tray. 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.