EKYClass I

Handpiece, Water-Powered

21 CFR 872.4200 / Dental

EKY is the FDA product code for Handpiece, Water-Powered, a class I device type, regulated under 21 CFR 872.4200. As of 2026-09-10, FDA records hold 2 510(k) clearances under this code, the most recent dated 2012-12-18, and no recalls.

Classification record

Product code: EKY
Device name: Handpiece, Water-Powered
Regulation: 21 CFR 872.4200
Device class: Class I
Review panel: Dental
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 2
Ingested recalls: 0

Clearances, product code EKY

By decision year

2 clearances under product code EKY with a decision year between 1990 and 2012, 1990 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code EKY by decision year
Year	Clearances
1990	1
2012	1

Applicants with the most clearances

Product code EKY

Applicants holding the most 510(k) clearances under product code EKY
Applicant	Clearances
Nevin Laboratories, Inc.	1
Saeshin Precision Co., Ltd.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

Recent clearances

Product code EKY

Recent recalls

Product code EKY

FDA records show no recalls under product code EKY.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)