KOM — Adhesive, Denture, Acacia And Karaya With Sodium Borate Class I

FDA Device Classification

FDA product code KOM covers "Adhesive, Denture, Acacia And Karaya With Sodium Borate", a Class I medical device regulated under 21 CFR 872.3400. Submissions are reviewed by the Dental panel. At least 1 recent 510(k) clearance has been granted under this product code.

Classification Details

Product Code
KOM
Device Class
Class I
Regulation Number
872.3400
Submission Type
Review Panel
DE
Medical Specialty
Dental
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K910216stiefel research instituteSTEADFAST DENTURE ADHESIVE POWDERMarch 29, 1991