OIV

Dental Amalgam

Product code

OIV

Device name

Dental Amalgam

Device class

Class 2

21 CFR

21 CFR 872.3070

Medical specialty

Dental

Marketing pathway

510(K)

Flag

Third-party review eligible

510(k) clearances (all years, FDA)

3 (all years; only the last 3 years are listed here)

FDA classification definition

Dental amalgam is a device that consists of a metallic alloy, such as silver, tin, copper, and zinc, that is mixed with liquid elemental mercury for the direct filling of carious lesions or structural defects in teeth

Definition text from the FDA device classification database (U.S. federal government work, public domain).