Home › OSUNG MND Co., Ltd. › OSUNG MND
OSUNG MND
OSUNG MND Co., Ltd. · Model RDPL1 · UDI-DI 08800075603449
1
510(k) clearances
11
Adverse events
4
Recalls
105
Facilities
Description
A hand-held dental instrument used for the insertion and removal of rubber dam clamps. It is typically designed with permanently joined handles pivoted scissors-like, and has small projections at the working end that fit into corresponding holes in the rubber dam clamp. It will typically have a sliding lock mechanism that locks the handles in position while the operator moves the rubber dam clamp around the tooth. This is a reusable device.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-06-03 | Coltene Whaledent Inc | Multiple Coltene batches of the product have a pin size larger than acceptable, which may make it difficult for the forceps to fit appropriately with dental dam clamps. |
| 2020-06-03 | Coltene Whaledent Inc | Multiple Coltene batches of the product have a pin size larger than acceptable, which may make it difficult for the forceps to fit appropriately with dental dam clamps. |
| 2020-06-03 | Coltene Whaledent Inc | Multiple Coltene batches of the product have a pin size larger than acceptable, which may make it difficult for the forceps to fit appropriately with dental dam clamps. |
| 2020-06-03 | Coltene Whaledent Inc | Multiple Coltene batches of the product have a pin size larger than acceptable, which may make it difficult for the forceps to fit appropriately with dental dam clamps. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
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.