MZW

2 FDA 510(k) clearances · Product code

FDA profile

Official device name

Dental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering For Pain Relief

Device class

Class II (moderate risk)

Regulation

21 CFR 872.3275

Medical specialty

Dental

Flags

Third-party review eligible

Adverse events (MAUDE)

2014: 13
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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