Mercury

Device Code: 1250

Product Code(s): ELY

Device Classification Information

Device Type ID1250
Device NameMercury
Regulation DescriptionDental Amalgam, Mercury, And Amalgam Alloy.
Regulation Medical SpecialtyDental
Review PanelDental
Premarket Review Office Of Device Evaluation (ODE)
Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID)
Dental Devices Branch (DEDB)
Submission Type510(k)
CFR Regulation Number872.3070 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeELY
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Program

Recognized Standards

Total Product Life Cycle

Device Type ID1250
DeviceMercury
Product CodeELY
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionDental Amalgam, Mercury, And Amalgam Alloy.
CFR Regulation Number872.3070 [🔎]
TPLC Last Update: 2019-04-02 19:50:40

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