STRONG Dental Handpieces
FDA 510(k) K181129 · Saeshin Precision Co., Ltd.
510(k) numberK181129
Submission
- Device name
- STRONG Dental Handpieces
- Applicant
- Saeshin Precision Co., Ltd.
Deagu, KR - Received
- April 30, 2018
- Decision date
- January 31, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
More from Nakanishi, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K251407 | Motor Handpiece and Control Unit (SDI10)EBW · Traditional | 01/30/2026SE |
| K233153 | Traus SSG10 Surgical SystemHBC · Traditional | 09/20/2024SE |
| K232938 | Traus SSG30 Surgical SystemHBC · Traditional | 09/16/2024SE |
| K221741 | TRAUS Air Dental HandpieceEFB · Traditional | 02/22/2023SE |
| K212043 | Traus EndoEKX · Special | 06/24/2022SE |
| K201292 | Traus SIP20EBW · Traditional | 02/11/2021SE |
| K192561 | Traus SUS20DZI · Traditional | 07/13/2020SE |
| K182892 | TRAUS Dental HandpiecesEGS · Traditional | 11/26/2019SE |
| K171436 | STRONG Dental HandpiecesEGS · Traditional | 01/05/2018SE |
| K151171 | Traus SUS10DZI · Traditional | 09/01/2015SE |
Questions and answers
When was STRONG Dental Handpieces cleared by the FDA?
STRONG Dental Handpieces (K181129) received a 510(k) decision of Substantially Equivalent on January 31, 2019, 276 days after the submission was received.
What is the product code of K181129?
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.