NEA

6 FDA 510(k) clearances · Product code

FDA profile

Official device name

Cement, Ear, Nose And Throat

Device class

Class II (moderate risk)

Regulation

21 CFR 872.3275

Medical specialty

Dental

Flags

Implant

Adverse events (MAUDE)

2002: 2 · 2003: 6
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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