Capsule, Dental, Amalgam

Device Code: 1110

Product Code(s): DZS

Device Classification Information

Device Type ID1110
Device NameCapsule, Dental, Amalgam
Regulation DescriptionDental Amalgam Capsule.
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 Number872.3110 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeDZS
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID1110
DeviceCapsule, Dental, Amalgam
Product CodeDZS
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionDental Amalgam Capsule.
CFR Regulation Number872.3110 [🔎]
TPLC Last Update: 2019-04-02 19:48:31

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