Dispenser, Mercury And/or Alloy

Device Code: 1168

Product Code(s): EHE

Device Classification Information

Device Type ID1168
Device NameDispenser, Mercury And/or Alloy
Regulation DescriptionMercury And Alloy Dispenser.
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) Exempt
CFR Regulation Number872.3080 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeEHE
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID1168
DeviceDispenser, Mercury And/or Alloy
Product CodeEHE
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionMercury And Alloy Dispenser.
CFR Regulation Number872.3080 [🔎]
TPLC Last Update: 2019-04-02 19:49:18

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