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SAFE DENT

BGSS Company Inc. · Model C6012 · UDI-DI 00854014003294

EFN
10
510(k) clearances
7
Adverse events
2
Recalls
207
Facilities

Description

C6012 4X4 NON WOVEN (4ply) -CASE

Recalls

DateFirmReason
2022-08-02Carwild CorporationSterility with new cotton source not validated
2016-03-31American Surgical CompanyProduct packaging defective compromising sterility

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Data 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.