Wax, Dental, Intraoral

Device Code: 1159

Product Code(s): EGD

Device Classification Information

Device Type ID1159
Device NameWax, Dental, Intraoral
Regulation DescriptionIntraoral Dental Wax.
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 Number872.6890 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeEGD
GMP ExemptYes
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID1159
DeviceWax, Dental, Intraoral
Product CodeEGD
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionIntraoral Dental Wax.
CFR Regulation Number872.6890 [🔎]
TPLC Last Update: 2019-04-02 19:49:10

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