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