EGS · Handpiece, Contra- And Right-Angle Attachment, Dental
Dental · 21 CFR 872.4200 · Class 1
Overview
| Product Code | EGS |
|---|---|
| Device Name | Handpiece, Contra- And Right-Angle Attachment, Dental |
| 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 (20 of 73)
Showing 20 most recent of 73 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K251869 | Disposable Prophy Angle (3399-60, 3399-090, 3399-105) | Premium Plus (Dongguan) Limited | Sep 15, 2025 | SESE |
| K240950 | Disposable Prophy Angle | Pacific Care Limited | May 28, 2025 | SESE |
| K240183 | Star E900 Handpiece Series | Dentalez, Inc., Stardental Division | Sep 19, 2024 | SESE |
| K230106 | General Cutting Straight | Nakanishi, Inc. | May 24, 2023 | SESE |
| K222518 | FX Contra | Nakanishi, Inc. | Nov 17, 2022 | SESE |
| K220874 | Smooth Drive contra angle and straight handpieces | Lares Research | Nov 7, 2022 | SESE |
| K220346 | Lotus Prophy Angle | Ajk Engineering, Inc. | Nov 7, 2022 | SESE |
| K220577 | Dental Handpiece, Model CA160, CA160L, and CA500L | Micro-Nx Co., Ltd. | Jul 29, 2022 | SESE |
| K213139 | SURGmatic S15 L Pro | Kavo Dental GmbH | Dec 21, 2021 | SESE |
| K202960 | General Cutting Contra Handpiece | Nakanishi, Inc. | Oct 27, 2020 | SESE |
| K182892 | TRAUS Dental Handpieces | Saeshin Precision Co., Ltd. | Nov 26, 2019 | SESE |
| K182999 | General Cutting Contra Handpiece | Nakanishi, Inc. | Apr 16, 2019 | SESE |
| K181129 | STRONG Dental Handpieces | Saeshin Precision Co., Ltd. | Jan 31, 2019 | SESE |
| K171436 | STRONG Dental Handpieces | Saeshin Precision Co., Ltd. | Jan 5, 2018 | SESE |
| K162856 | Bonart Dental Handpieces (ART), Disposable Prophy Angle (PROFORMANCE) | Bonart Co., Ltd. | Jul 18, 2017 | SESE |
| K162397 | Titan 3 Low Speed Angle Attachments | Dentalez, Inc. | Jan 19, 2017 | SESE |
| K133178 | LUXATOR LX HANDPIECE | Directa AB | Nov 24, 2015 | SESE |
| K143418 | STRONG Dental Handpieces | Saeshin Precision Co., Ltd. | Jul 31, 2015 | SESE |
| K150750 | Endo 6:1, T1 Line Endo 6 L, SIRONiTi Apex, T1 Spray | Sirona Dental Systems GmbH | Jul 2, 2015 | SESE |
| K141125 | U-TYPE CONTRA ANGLE, U-TYPE SECTIONAL CONTRA ANGLE | Handpiece Headquarters | Oct 23, 2014 | SESE |
Top Applicants
- Nakanishi, Inc. — 5 clearances
- Saeshin Precision Co., Ltd. — 5 clearances
- Micro-Mega Societe Anonyme — 4 clearances
- Angstrom Mfg., Inc. — 2 clearances
- Aseptico, Inc. — 2 clearances
