Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart E — Surgical Devices](/submissions/DE/subpart-e%E2%80%94surgical-devices) → [21 CFR 872.4200](/submissions/DE/subpart-e%E2%80%94surgical-devices/872.4200) → EKY — Handpiece, Water-Powered

# EKY · Handpiece, Water-Powered

_Dental · 21 CFR 872.4200 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EKY

## Overview

- **Product Code:** EKY
- **Device Name:** Handpiece, Water-Powered
- **Regulation:** [21 CFR 872.4200](/submissions/DE/subpart-e%E2%80%94surgical-devices/872.4200)
- **Device Class:** 1
- **Review Panel:** [Dental](/submissions/DE)
- **3rd-party reviewable:** yes

## Identification

A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.

## Classification Rationale

Class I.

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K123695](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EKY/K123695.md) | TRAUS SIP10 | Saeshin Precision Co., Ltd. | Dec 18, 2012 | SESE |
| [K896364](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EKY/K896364.md) | DECIDENT | Nevin Laboratories, Inc. | Jul 19, 1990 | SESE |

## Top Applicants

- Nevin Laboratories, Inc. — 1 clearance
- Saeshin Precision Co., Ltd. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EKY](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EKY)

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