Bonart Dental Handpieces (ART), Disposable Prophy Angle (PROFORMANCE)
FDA 510(k) K162856 · Bonart Co., Ltd.
510(k) numberK162856
Submission
- Device name
- Bonart Dental Handpieces (ART), Disposable Prophy Angle (PROFORMANCE)
- Applicant
- Bonart Co., Ltd.
Keelung City, TW - Received
- October 12, 2016
- Decision date
- July 18, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) statement available from FDA
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| K251869 | Disposable Prophy Angle (3399-60, 3399-090, 3399-105)EGS · Traditional | Premium Plus (Dongguan) Limited | 09/15/2025SE |
| K240950 | Disposable Prophy AngleEGS · Abbreviated | Pacific Care Limited | 05/28/2025SE |
| K240183 | Star E900 Handpiece SeriesEGS · Traditional | Dentalez, Inc., Stardental Division | 09/19/2024SE |
| K230106 | General Cutting StraightEGS · Traditional | Nakanishi, Inc. | 05/24/2023SE |
| K222518 | FX ContraEGS · Traditional | Nakanishi, Inc. | 11/17/2022SE |
| K220874 | Smooth Drive contra angle and straight handpiecesEGS · Traditional | Lares Research | 11/07/2022SE |
| K220346 | Lotus Prophy AngleEGS · Traditional | Ajk Engineering, Inc. | 11/07/2022SE |
| K220577 | Dental Handpiece, Model CA160, CA160L, and CA500LEGS · Traditional | Micro-Nx Co., Ltd. | 07/29/2022SE |
| K213139 | SURGmatic S15 L ProEGS · Traditional | Kavo Dental GmbH | 12/21/2021SE |
| K202960 | General Cutting Contra HandpieceEGS · Special | Nakanishi, Inc. | 10/27/2020SE |
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| 510(k) | Device | Decision |
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| K100785 | Bonart Model ART-IM1 Implantor System & AccessoriesEBW · Traditional | 12/03/2010SE |
| K082971 | Bonart ART-L5 LED Cordless Curing LightEBZ · Traditional | 11/13/2008SE |
| K081550 | Bonart Ultrasonic Scaler, Moedls ART-P3II Pro and Art-Mii ProELC · Traditional | 08/28/2008SE |
| K080761 | Bonart's Arteotomy Omi and Opi Ultrasonic Surgery System & AccessoriesDZI · Traditional | 08/25/2008SE |
| K071981 | Bonart Model ART-P6 Piezo Electric Ultrasonic Scaler & Accessories (Tips)ELC · Traditional | 10/26/2007SE |
| K062289 | Bonart ART-L3 LED Curing LightEBZ · Traditional | 01/03/2007SE |
| K061448 | Bonart ART-P3II & P4 Piezo Electric Ultrasonic Scaler Units with AccessoriesELC · Traditional | 08/17/2006SE |
| K052028 | Bonart ART-M3II & M4 Ultrasonic Scaler Units with Accessories (Inserts)ELC · Traditional | 10/28/2005SE |
| K023721 | Bonart ART-L2 Light Curing UnitEBZ · Traditional | 01/10/2003SE |
Questions and answers
When was Bonart Dental Handpieces (ART), Disposable Prophy Angle (PROFORMANCE) cleared by the FDA?
Bonart Dental Handpieces (ART), Disposable Prophy Angle (PROFORMANCE) (K162856) received a 510(k) decision of Substantially Equivalent on July 18, 2017, 279 days after the submission was received.
What is the product code of K162856?
The FDA product code is EGS – Handpiece, Contra- And Right-Angle Attachment, Dental, a Class I (low risk) device regulated under 21 CFR 872.4200.