Teeth, Artificial, Backing And Facing

Device Code: 1242

Product Code(s): ELK

Device Classification Information

Device Type ID1242
Device NameTeeth, Artificial, Backing And Facing
Regulation DescriptionBacking And Facing For An Artificial 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 Number872.3910 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeELK
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID1242
DeviceTeeth, Artificial, Backing And Facing
Product CodeELK
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionBacking And Facing For An Artificial Tooth.
CFR Regulation Number872.3910 [🔎]
TPLC Last Update: 2019-04-02 19:50:32

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