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Dental Amalgam

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.

Global Registration Data
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Dental Amalgam
Dental Medical Device Type
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Regulatory Classifications

US Regulatory Classifications

OIV

View Product Code Classification

Class 2

21 CFR 872.3070

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Dental

Device Characteristics

No

No

No

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