Syringe, Restorative And Impression Material

Device Code: 1183

Product Code(s): EID

Device Classification Information

Device Type ID1183
Device NameSyringe, Restorative And Impression Material
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 CodeEID
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID1183
DeviceSyringe, Restorative And Impression Material
Product CodeEID
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionDental Hand Instrument.
CFR Regulation Number872.4565 [🔎]
Recalls
Manufacturer Recall Class Date Posted
1
Ultradent Products, Inc.
II Jan-17-2017
TPLC Last Update: 2019-04-02 19:49:33

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