Device, Jaw Tracking, For Monitoring Jaw Positions

Device Code: 1337

Product Code(s): NFS

Device Classification Information

Device Type ID1337
Device NameDevice, Jaw Tracking, For Monitoring Jaw Positions
Regulation DescriptionJaw Tracking Device.
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 Number872.2060 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeNFS
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID1337
DeviceDevice, Jaw Tracking, For Monitoring Jaw Positions
Product CodeNFS
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionJaw Tracking Device.
CFR Regulation Number872.2060 [🔎]
TPLC Last Update: 2019-04-02 19:52:14

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.