Denture Preformed (partially Prefabricated Denture)

Device Code: 1227

Product Code(s): EKO

Device Classification Information

Device Type ID1227
Device NameDenture Preformed (partially Prefabricated Denture)
Regulation DescriptionPartially Fabricated Denture Kit.
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 Number872.3600 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeEKO
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

Total Product Life Cycle

Device Type ID1227
DeviceDenture Preformed (partially Prefabricated Denture)
Product CodeEKO
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionPartially Fabricated Denture Kit.
CFR Regulation Number872.3600 [🔎]
TPLC Last Update: 2019-04-02 19:50:18

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