Material, Impression Tray, Resin

Device Code: 1123

Product Code(s): EBH

Device Classification Information

Device Type ID1123
Device NameMaterial, Impression Tray, Resin
Regulation DescriptionResin Impression Tray Material.
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 Number872.3670 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeEBH
GMP ExemptYes
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID1123
DeviceMaterial, Impression Tray, Resin
Product CodeEBH
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionResin Impression Tray Material.
CFR Regulation Number872.3670 [🔎]
TPLC Last Update: 2019-04-02 19:48:42

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