EHS — Cushion, Denture, Over The Counter Class II

FDA Device Classification

FDA product code EHS covers "Cushion, Denture, Over The Counter", a Class II medical device regulated under 21 CFR 872.3540. Submissions are reviewed by the Dental panel. At least 3 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
EHS
Device Class
Class II
Regulation Number
872.3540
Submission Type
Review Panel
DE
Medical Specialty
Dental
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K971002lloyd v. ziemendorfSMILE WITH CONFIDENCEJuly 15, 1997
K813190leonard russoSOFT PLATE CUSHIONFebruary 5, 1982
K770413combeCUSHIONS, DENTURE ADHESIVE, ALL-DAYJune 24, 1977