Implant, Subperiosteal

Device Code: 1240

Product Code(s): ELE

Device Classification Information

Device Type ID1240
Device NameImplant, Subperiosteal
Regulation DescriptionSubperiosteal Implant Material.
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)
CFR Regulation Number872.3645 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeELE
GMP ExemptNo
Summary MREligible
Implanted DeviceYes
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID1240
DeviceImplant, Subperiosteal
Product CodeELE
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionSubperiosteal Implant Material.
CFR Regulation Number872.3645 [🔎]
Device Problems
Break
1
Fracture
1
Total Device Problems 2
TPLC Last Update: 2019-04-02 19:50:30

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