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KXX — Adhesive, Denture, Karaya And Ethylene-Oxide Homopolymer Class I

FDA Device Classification

FDA product code KXX covers "Adhesive, Denture, Karaya And Ethylene-Oxide Homopolymer", a Class I medical device regulated under 21 CFR 872.3450. 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
KXX
Device Class
Class I
Regulation Number
872.3450
Submission Type
Review Panel
DE
Medical Specialty
Dental
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K863375combeSEA-BONDSeptember 19, 1986

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