Traus SUS20
FDA 510(k) K192561 · Saeshin Precision Co., Ltd.
510(k) numberK192561
Submission
- Device name
- Traus SUS20
- Applicant
- Saeshin Precision Co., Ltd.
Deagu, KR - Received
- September 17, 2019
- Decision date
- July 13, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code DZI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253655 | Angled Screwdriver MED (M-SD090)DZI · Traditional | W&H Dentalwerk Bürmoos GmbH | 07/31/2026SE |
| K253776 | Implantmed Plus II & Piezomed Plus II ModuleDZI · Traditional | W&H Dentalwerk Buermoos GmbH | 06/18/2026SE |
| K254163 | VarioSurg 4DZI · Traditional | Nakanishi, Inc. | 12/23/2025SE |
| K242432 | MT-BoneDZI · Traditional | Mectron S.P.A. | 08/19/2024SE |
| K240340 | Surgical Drive System (Model: ES70, ES90, E8)DZI · Traditional | Guangdong Jinme Medical Technology Co., Ltd. | 07/18/2024SE |
| K231087 | Guided Surgery KitDZI · Traditional | Implant Direct Sybron Manufacturing, LLC | 08/16/2023SE |
| K200265 | Surgical DrillsDZI · Traditional | Implant Direct Sybron Manufacturing, LLC | 06/30/2020SE |
| K192033 | Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip, Contour P-Insert WC…DZI · Traditional | Bennett Jacoby, Dds, Ms, Inc. | 06/09/2020SE |
| K172137 | Piezotome CubeDZI · Traditional | Satelec - Acteon Group | 05/03/2018SE |
| K171326 | Piezosurgery WhiteDZI · Traditional | Mectron S.P.A. | 04/13/2018SE |
More from Mectron S.P.A.
| 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 |
| 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 SUS20 cleared by the FDA?
Traus SUS20 (K192561) received a 510(k) decision of Substantially Equivalent on July 13, 2020, 300 days after the submission was received.
What is the product code of K192561?
The FDA product code is DZI – Drill, Bone, Powered, a Class II (moderate risk) device regulated under 21 CFR 872.4120.