OIV · Class II — Moderate Risk (510(k) clearance required) · Dental · 21 CFR 872.3070
Classification
FDA Product Code
OIV
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 872.3070
Review panel
DE
Medical specialty
Dental
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
Y
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