Syringe, Irrigating (dental)

Device Code: 1181

Product Code(s): EIB

Device Classification Information

Device Type ID1181
Device NameSyringe, Irrigating (dental)
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 CodeEIB
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

Total Product Life Cycle

Device Type ID1181
DeviceSyringe, Irrigating (dental)
Product CodeEIB
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionDental Hand Instrument.
CFR Regulation Number872.4565 [🔎]
TPLC Last Update: 2019-04-02 19:49:31

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