Traus Endo
FDA 510(k) K143411 · Saeshin Precision Co., Ltd.
510(k) numberK143411
Submission
- Device name
- Traus Endo
- Applicant
- Saeshin Precision Co., Ltd.
Daegu, KR - Received
- November 28, 2014
- Decision date
- June 29, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K261987 | Reusable SmartPegEKX · Traditional | Osstell AB | 09/08/2026SE |
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| K251597 | InnerView SystemEKX · Traditional | Perimetrics, Inc. | 09/18/2025SE |
| K243692 | EnDrive (EnDriveUS)EKX · Traditional | Advanced Technology Research (A.T.R.) S.R.L. | 08/22/2025SE |
| K242514 | Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO)EKX · Traditional | Shenzhen Rogin Medical Co., Ltd. | 04/24/2025SE |
| K241065 | ChecQ (AC100)EKX · Traditional | Dentis Co., Ltd. | 03/21/2025SE |
| K243911 | HPR Cordless Hygiene HandpieceEKX · Traditional | Handpiece Headquarters | 12/20/2024SE |
| K222688 | The TrustEKX · Traditional | Genoss Co., Ltd. | 08/09/2024SE |
| K233865 | X-Smart Pro; X-Smart Pro+EKX · Traditional | Dentsply Sirona, Inc. | 07/24/2024SE |
| K232551 | EM-07 Cordless Endo MotorEKX · Traditional | Forum Engineering Technologies (96) , Ltd. | 07/09/2024SE |
More from Forum Engineering Technologies (96) , Ltd.
| 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 |
| K181129 | STRONG Dental HandpiecesEGS · Traditional | 01/31/2019SE |
| K171436 | STRONG Dental HandpiecesEGS · Traditional | 01/05/2018SE |
Questions and answers
When was Traus Endo cleared by the FDA?
Traus Endo (K143411) received a 510(k) decision of Substantially Equivalent on June 29, 2015, 213 days after the submission was received.
What is the product code of K143411?
The FDA product code is EKX – Handpiece, Direct Drive, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 872.4200.