Implant, Temporal

Device Code: 5748

Product Code(s): MNF

Device Classification Information

Device Type ID5748
Device NameImplant, Temporal
Regulation DescriptionChin Prosthesis.
Regulation Medical SpecialtyGeneral & Plastic Surgery
Review PanelGeneral & Plastic Surgery
Premarket Review Office Of Device Evaluation (ODE)
Division Of Surgical Devices (DSD)
General Surgery Devices Branch One - Light Based/Laser (GSDB1)
Submission Type510(k)
CFR Regulation Number878.3550 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeMNF
GMP ExemptNo
Summary MREligible
Implanted DeviceYes
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5748
DeviceImplant, Temporal
Product CodeMNF
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionChin Prosthesis.
CFR Regulation Number878.3550 [🔎]
TPLC Last Update: 2019-04-02 21:11:52

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