EKY · Handpiece, Water-Powered
Dental · 21 CFR 872.4200 · Class 1
Overview
| Product Code | EKY |
|---|---|
| Device Name | Handpiece, Water-Powered |
| 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 (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K123695 | TRAUS SIP10 | Saeshin Precision Co., Ltd. | Dec 18, 2012 | SESE |
| K896364 | DECIDENT | Nevin Laboratories, Inc. | Jul 19, 1990 | SESE |
Top Applicants
- Nevin Laboratories, Inc. — 1 clearance
- Saeshin Precision Co., Ltd. — 1 clearance
