Holder, Film, X-ray

Device Code: 1166

Product Code(s): EGZ

Device Classification Information

Device Type ID1166
Device NameHolder, Film, X-ray
Regulation DescriptionDental X-ray Film Holder.
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 Number872.1905 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeEGZ
GMP ExemptYes
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID1166
DeviceHolder, Film, X-ray
Product CodeEGZ
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionDental X-ray Film Holder.
CFR Regulation Number872.1905 [🔎]
TPLC Last Update: 2019-04-02 19:49:15

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