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) → NYL — Handpiece, Air-Powered, Root Canal Irrigation

# NYL · Handpiece, Air-Powered, Root Canal Irrigation

_Dental · 21 CFR 872.4200 · Class 1_

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

## Overview

- **Product Code:** NYL
- **Device Name:** Handpiece, Air-Powered, Root Canal Irrigation
- **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 (5 of 5)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K211721](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/NYL/K211721.md) | PS System | Inter-Med, Inc. | Dec 2, 2021 | SESE |
| [K162436](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/NYL/K162436.md) | EndoVac Pure | Kerr Corporation | Dec 21, 2016 | SESE |
| [K140685](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/NYL/K140685.md) | ENDO VAC APICAL NEGATIVE PRESSURE IRIGATION SYSTEM | Sybron Endo | Jul 2, 2014 | SESE |
| [K100606](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/NYL/K100606.md) | VATEA ENDONTIC IRRIGATION SYSTEM | Redent Nova, Ltd. | May 28, 2010 | SESE |
| [K052271](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/NYL/K052271.md) | RINSENDO | Air Techniques, Inc. | May 26, 2006 | SESE |

## Top Applicants

- Air Techniques, Inc. — 1 clearance
- Inter-Med, Inc. — 1 clearance
- Kerr Corporation — 1 clearance
- Redent Nova, Ltd. — 1 clearance
- Sybron Endo — 1 clearance

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

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