EKZ

19 FDA 510(k) clearances · Product code

FDA profile

Official device name

Unit, Electrosurgical, And Accessories, Dental

Device class

Class II (moderate risk)

Regulation

21 CFR 872.4920

Medical specialty

Dental

Flags

Third-party review eligible

Adverse events (MAUDE)

1992: 1 · 1993: 1 · 1999: 1 · 2000: 1 · 2004: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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