Articulators

Device Code: 1204

Product Code(s): EJP

Device Classification Information

Device Type ID1204
Device NameArticulators
Regulation DescriptionArticulator.
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 Number872.3150 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeEJP
GMP ExemptYes
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID1204
DeviceArticulators
Product CodeEJP
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionArticulator.
CFR Regulation Number872.3150 [🔎]
TPLC Last Update: 2019-04-02 19:49:57

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