Facebow

Device Code: 1279

Product Code(s): KCR

Device Classification Information

Device Type ID1279
Device NameFacebow
Regulation DescriptionFacebow.
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 Number872.3220 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeKCR
GMP ExemptYes
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID1279
DeviceFacebow
Product CodeKCR
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionFacebow.
CFR Regulation Number872.3220 [🔎]
TPLC Last Update: 2019-04-02 19:51:13

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