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Dental Amalgam

FDA product code OIV · 2 cleared devices

Class 2 Dental
Regulation
21 CFR 872.3070
Review panel
DE
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
2008-07-10 – 2023-05-01

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

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