Adhesive, Denture, Karaya And Ethylene-oxide Homopolymer

Device Code: 1302

Product Code(s): KXX

Device Classification Information

Device Type ID1302
Device NameAdhesive, Denture, Karaya And Ethylene-oxide Homopolymer
Regulation DescriptionEthylene Oxide Homopolymer And/or Karaya Denture Adhesive.
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 Number872.3450 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeKXX
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID1302
DeviceAdhesive, Denture, Karaya And Ethylene-oxide Homopolymer
Product CodeKXX
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionEthylene Oxide Homopolymer And/or Karaya Denture Adhesive.
CFR Regulation Number872.3450 [🔎]
TPLC Last Update: 2019-04-02 19:51:39

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