Point, Silver, Endodontic

Device Code: 1224

Product Code(s): EKL

Device Classification Information

Device Type ID1224
Device NamePoint, Silver, Endodontic
Regulation DescriptionEndodontic Silver Point.
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 Number872.3840 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeEKL
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID1224
DevicePoint, Silver, Endodontic
Product CodeEKL
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionEndodontic Silver Point.
CFR Regulation Number872.3840 [🔎]
TPLC Last Update: 2019-04-02 19:50:16

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