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OSUNG MND
OSUNG MND Co., Ltd. · Model RDPN1 · UDI-DI 08800075612854
3
510(k) clearances
6
Adverse events
1
Recalls
86
Facilities
Description
A hand-held dental instrument used to place holes in rubber dam material to permit the passage of the dam over the crowns of the teeth. The handles are squeezed together and the plunger (punch) creates a hole in the rubber dam material. It is typically designed to create various hole sizes. This is a reusable device.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-03-30 | Omnia SRL | Omnia SRL received a notification from the contract manufacturer informing them of inadequate sterilization processes which have been taking place at their contracted sterilizing f |
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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.