Paper, Articulation

Device Code: 1151

Product Code(s): EFH

Device Classification Information

Device Type ID1151
Device NamePaper, Articulation
Regulation DescriptionArticulation Paper.
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 Number872.6140 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeEFH
GMP ExemptYes
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID1151
DevicePaper, Articulation
Product CodeEFH
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionArticulation Paper.
CFR Regulation Number872.6140 [🔎]
Device Problems
Patient-Device Incompatibility
1
Total Device Problems 1
TPLC Last Update: 2019-04-02 19:49:03

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