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FDA product code OIV

Dental Amalgam

DentalClass 221 CFR 872.3070
Verified
US regulatory classifications
US Product Code (FDA)
OIV
View Product Code Classification
US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 872.3070
View CFR Regulation
Medical specialty
Dental
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Eligible
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

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About this record

Dental Amalgam is a medical device type in the Dental specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.