Teeth, Preformed Gold Denture

Device Code: 1245

Product Code(s): ELN

Device Classification Information

Device Type ID1245
Device NameTeeth, Preformed Gold Denture
Regulation DescriptionPreformed Gold Denture Tooth.
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 Number872.3580 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeELN
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID1245
DeviceTeeth, Preformed Gold Denture
Product CodeELN
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionPreformed Gold Denture Tooth.
CFR Regulation Number872.3580 [🔎]
TPLC Last Update: 2019-04-02 19:50:34

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