EKA

2 FDA 510(k) clearances · Product code

FDA profile

Official device name

File, Margin Finishing, Operative

Device class

Class I (low risk)

Regulation

21 CFR 872.4565

Medical specialty

Dental

Adverse events (MAUDE)

2004: 3 · 2008: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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