KOP

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Adhesive, Denture, Karaya

Device class

Class I (low risk)

Regulation

21 CFR 872.3450

Medical specialty

Dental

Adverse events (MAUDE)

1997: 2 · 1999: 1 · 2000: 3 · 2003: 5 · 2004: 22 · 2005: 4
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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