Applicator, Resin

Device Code: 1300

Product Code(s): KXR

Device Classification Information

Device Type ID1300
Device NameApplicator, Resin
Regulation DescriptionResin Applicator.
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 Number872.3140 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeKXR
GMP ExemptYes
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID1300
DeviceApplicator, Resin
Product CodeKXR
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionResin Applicator.
CFR Regulation Number872.3140 [🔎]
TPLC Last Update: 2019-04-02 19:51:37

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