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Monolith Prophy Powder Genie Smile TOP "Spearmint"

PRISMAN INC. · Model M515 · UDI-DI 04064896000465

EJR
10
510(k) clearances
102
Adverse events (1 deaths)
1
Recalls
146
Facilities

Recalls

DateFirmReason
2024-05-13Young Dental Manufacturing I, LLCPart number 040032, Lot number, 248607 was incorrectly labeled as part number 045032

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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.