Most dental devices are Class I. But some dental devices are
Class II. Compliance Consultants has submitted 510(k)
applications for many Class II: diagnostic, prosthetic
software, surgical, therapeutic and dental crown & bridge
resins devices by submitting 510(k)s.
The department of Health & Human Services that runs the Food and Drug Administration that runs the Center for Devices and Radiological Health seems to have blocked the promised CDRH Decision on Dental Amalgam material since it contains mercury. A final rule was due in 2009 for this Class II device. Dental Amalgam rule is not forth coming. The American Dental Association (ADA) is strongly in favor of keeping mercury-laced dental amalgam and it publicly minimizes the neurotoxin's risks.
Regulation Number:21 CFR 872.1810, Product Code: EAP
Regulation Number:21 CFR 872.3770, Product Code: EBG
Regulation Number:21 CFR 872.3810, Product Code: ELR
The department of Health & Human Services that runs the Food and Drug Administration that runs the Center for Devices and Radiological Health seems to have blocked the promised CDRH Decision on Dental Amalgam material since it contains mercury. A final rule was due in 2009 for this Class II device. Dental Amalgam rule is not forth coming. The American Dental Association (ADA) is strongly in favor of keeping mercury-laced dental amalgam and it publicly minimizes the neurotoxin's risks.
Regulation Number:21 CFR 872.1810, Product Code: EAP
Regulation Number:21 CFR 872.3770, Product Code: EBG
Regulation Number:21 CFR 872.3810, Product Code: ELR
