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EBE — Coating, Denture Hydrophilic, Resin Class II

FDA Device Classification

FDA product code EBE covers "Coating, Denture Hydrophilic, Resin", a Class II medical device regulated under 21 CFR 872.3300. 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
EBE
Device Class
Class II
Regulation Number
872.3300
Submission Type
Review Panel
DE
Medical Specialty
Dental
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K832500chema-scutumCS-11October 27, 1983
K830491johnson and johnson professionalsJOHNSON & JOHNSON OPAQUE COLOR MODIFIMarch 17, 1983
K790339richardson merrelCONCEPT IIJuly 17, 1979

FDA data resources