Scissors, Collar And Crown

Device Code: 1190

Product Code(s): EIR

Device Classification Information

Device Type ID1190
Device NameScissors, Collar And Crown
Regulation DescriptionDental Hand Instrument.
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 Number872.4565 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeEIR
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID1190
DeviceScissors, Collar And Crown
Product CodeEIR
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionDental Hand Instrument.
CFR Regulation Number872.4565 [🔎]
TPLC Last Update: 2019-04-02 19:49:44

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