Adhesive, Denture, Carboxymethylcellulose Sodium (40-100&)

Device Code: 1296

Product Code(s): KOQ

Device Classification Information

Device Type ID1296
Device NameAdhesive, Denture, Carboxymethylcellulose Sodium (40-100&)
Regulation DescriptionEthylene Oxide Homopolymer And/or Carboxymethylcellulose Sodium 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 Number872.3410 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeKOQ
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID1296
DeviceAdhesive, Denture, Carboxymethylcellulose Sodium (40-100&)
Product CodeKOQ
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionEthylene Oxide Homopolymer And/or Carboxymethylcellulose Sodium Denture Adhesive.
CFR Regulation Number872.3410 [🔎]
TPLC Last Update: 2019-04-02 19:51:32

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