Company ยท KR
Saeshin Precision Co., Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2009 to 2026. Name variants (Inc, Corp, punctuation) are merged.
18510(k) clearances (1 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| EGS | Handpiece, Contra- And Right-Angle Attachment, Dental | 5 |
| EBW | Controller, Foot, Handpiece And Cord | 3 |
| EKX | Handpiece, Direct Drive, Ac-Powered | 3 |
| DZI | Drill, Bone, Powered | 2 |
| HBC | Motor, Drill, Electric | 2 |
| EFA | Handpiece, Belt And/Or Gear Driven, Dental | 1 |
| EFB | Handpiece, Air-Powered, Dental | 1 |
| EKY | Handpiece, Water-Powered | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 30, 2026 | K251407 | Motor Handpiece and Control Unit (SDI10) Saeshin Precision Co., Ltd., KR | EBW |
| Sep 20, 2024 | K233153 | Traus SSG10 Surgical System Saeshin Precision Co., Ltd., KR | HBC |
| Sep 16, 2024 | K232938 | Traus SSG30 Surgical System Saeshin Precision Co., Ltd., KR | HBC |
| Feb 22, 2023 | K221741 | TRAUS Air Dental Handpiece Saeshin Precision Co., Ltd., KR | EFB |
| Jun 24, 2022 | K212043 | TRAUS ENDO Saeshin Precision Co., Ltd., KR | EKX |
| Feb 11, 2021 | K201292 | TRAUS SIP20 Saeshin Precision Co., Ltd., KR | EBW |
| Jul 13, 2020 | K192561 | TRAUS SUS20 Saeshin Precision Co., Ltd., KR | DZI |
| Nov 26, 2019 | K182892 | TRAUS Dental Handpieces Saeshin Precision Co., Ltd., KR | EGS |
| Jan 31, 2019 | K181129 | STRONG Dental Handpieces Saeshin Precision Co., Ltd., KR | EGS |
| Jan 5, 2018 | K171436 | STRONG Dental Handpieces Saeshin Precision Co., Ltd., KR | EGS |
| Sep 1, 2015 | K151171 | TRAUS SUS10 Saeshin Precision Co., Ltd., KR | DZI |
| Jul 31, 2015 | K143418 | STRONG Dental Handpieces Saeshin Precision Co., Ltd., KR | EGS |
| Jun 29, 2015 | K143411 | TRAUS ENDO Saeshin Precision Co., Ltd., KR | EKX |
| Dec 18, 2012 | K123695 | TRAUS SIP10 Saeshin Precision Co., Ltd., KR | EKY |
| Aug 19, 2011 | K111616 | E-CUBE Saeshin Precision Co., Ltd., KR | EKX |
| Feb 4, 2010 | K100192 | STRONG DENTAL HANDPIECES Saeshin Precision Co., Ltd., KR | EGS |
| Sep 21, 2009 | K092758 | X-CUBE Saeshin Precision Co., Ltd., KR | EBW |
| Sep 3, 2009 | K092412 | STRONG IMPLANT HANDPIECES Saeshin Precision Co., Ltd., KR | EFA |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||