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SAFE DENT
BGSS Company Inc. · Model C6013 · UDI-DI 00854014003331
10
510(k) clearances
7
Adverse events
2
Recalls
206
Facilities
Description
C6013 #2 MED. COTTON ROLLS 1.5 X 3/8-INNER BOX
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-08-02 | Carwild Corporation | Sterility with new cotton source not validated |
| 2016-03-31 | American Surgical Company | Product packaging defective compromising sterility |
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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.