NYL · Handpiece, Air-Powered, Root Canal Irrigation
Dental · 21 CFR 872.4200 · Class 1
Overview
| Product Code | NYL |
|---|---|
| Device Name | Handpiece, Air-Powered, Root Canal Irrigation |
| Regulation | 21 CFR 872.4200 |
| Device Class | Class 1 |
| Review Panel | Dental |
| 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 | PS System | Inter-Med, Inc. | Dec 2, 2021 | SESE |
| K162436 | EndoVac Pure | Kerr Corporation | Dec 21, 2016 | SESE |
| K140685 | ENDO VAC APICAL NEGATIVE PRESSURE IRIGATION SYSTEM | Sybron Endo | Jul 2, 2014 | SESE |
| K100606 | VATEA ENDONTIC IRRIGATION SYSTEM | Redent Nova, Ltd. | May 28, 2010 | SESE |
| K052271 | 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
