EKY — Handpiece, Water-Powered Class I

FDA Device Classification

FDA product code EKY covers "Handpiece, Water-Powered", a Class I medical device regulated under 21 CFR 872.4200. Submissions are reviewed by the Dental panel. At least 2 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
EKY
Device Class
Class I
Regulation Number
872.4200
Submission Type
Review Panel
DE
Medical Specialty
Dental
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K123695saeshin precision coTRAUS SIP10December 18, 2012
K896364nevin laboratoriesDECIDENTJuly 19, 1990