Traus SIP20
FDA 510(k) K201292 · Saeshin Precision Co., Ltd.
510(k) numberK201292
Submission
- Device name
- Traus SIP20
- Applicant
- Saeshin Precision Co., Ltd.
Deagu, KR - Received
- May 14, 2020
- Decision date
- February 11, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code EBW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251407 | Motor Handpiece and Control Unit (SDI10)EBW · Traditional | Saeshin Precision Co., Ltd. | 01/30/2026SE |
| K251701 | Star E900 Electric SystemEBW · Traditional | Dentalez, Inc., Stardental Division | 01/12/2026SE |
| K251811 | Motor and Apex Module (MaAM)EBW · Traditional | Dentsply Sirona, Inc. | 08/25/2025SE |
| K231562 | ELEC ENGINE (Model: ISE-170L)EBW · Special | Micro-Nx Co., Ltd. | 07/18/2025SE |
| K242646 | Dental Implant UnitEBW · Traditional | Guilin Aesthedent Medical Instruments Co., Ltd. | 04/11/2025SE |
| K233288 | NLZ Built-In Motor SystemEBW · Traditional | Nakanishi, Inc. | 06/24/2024SE |
| K233117 | Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT)EBW · Traditional | Nakanishi, Inc. | 06/20/2024SE |
| K230895 | CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMr L FLUO, i-MMs, i-MMs FLUO; i-XR3, i-XR3…EBW · Traditional | Cefla S.C. | 04/01/2024SE |
| K231864 | Fiber Optic Brushless Electronic Micromotor, model: iM100EBW · Traditional | Codent Technical Industry Co., Ltd. | 03/11/2024SE |
| K211358 | Implanter incl. AccessoriesEBW · Traditional | Guilin Woodpecker Medical Instrument Co., Ltd. | 11/21/2022SE |
More from Guilin Woodpecker Medical Instrument Co., 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 |
| 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 |
| K151171 | Traus SUS10DZI · Traditional | 09/01/2015SE |
Questions and answers
When was Traus SIP20 cleared by the FDA?
Traus SIP20 (K201292) received a 510(k) decision of Substantially Equivalent on February 11, 2021, 273 days after the submission was received.
What is the product code of K201292?
The FDA product code is EBW – Controller, Foot, Handpiece And Cord, a Class I (low risk) device regulated under 21 CFR 872.4200.