Polyvinyl Methylether Maleic Anhydride &/or Acid Copolymer & Carboxymethylce

Device Code: 1303

Product Code(s): KXY

Definition: Call For PMAs 12/26/96 Per 61 FR 50707 On 9/27/96

Device Classification Information

Device Type ID1303
Device NamePolyvinyl Methylether Maleic Anhydride &/or Acid Copolymer & Carboxymethylce
Regulation DescriptionPolyvinylmethylether Maleic Anhydride (PVM-MA), Acid Copolymer, And Carboxymethylcellulose Sodium (NACMC) 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 TypePMA
CFR Regulation Number872.3500 [🔎]
FDA Device ClassificationClass 3 Medical Device
Product CodeKXY
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID1303
DevicePolyvinyl Methylether Maleic Anhydride &/or Acid Copolymer & Carboxymethylce
Product CodeKXY
FDA Device ClassificationClass 3 Medical Device
Regulation DescriptionPolyvinylmethylether Maleic Anhydride (PVM-MA), Acid Copolymer, And Carboxymethylcellulose Sodium (NACMC) Denture Adhesive.
CFR Regulation Number872.3500 [🔎]
TPLC Last Update: 2019-04-02 19:51:40

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