Saeshin Precision Co., Ltd.: FDA filings under this applicant name
FDA lists 18 510(k) clearances under the applicant name “Saeshin Precision Co., Ltd.” (first 2009, latest 2026), across 8 product codes in 2 review panels. Median 510(k) review time under this name: 248 days. Since 2017 the median was 288 days, against 253 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 15 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 3 | 213 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 234 |
| 2019 | 2 | 342 |
| 2020 | 1 | 300 |
| 2021 | 1 | 273 |
| 2022 | 1 | 359 |
| 2023 | 1 | 252 |
| 2024 | 2 | 360 |
| 2025 | 0 | — |
| 2026 | 1 | 269 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Saeshin Precision Co., Ltd. took a median 288 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 253 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EGS | Handpiece, Contra- And Right-Angle Attachment, Dental | 5 | 5 |
| EBW | Controller, Foot, Handpiece And Cord | 3 | 3 |
| EKX | Handpiece, Direct Drive, Ac-Powered | 3 | 3 |
| DZI | Drill, Bone, Powered | 2 | 2 |
| HBC | Motor, Drill, Electric | 2 | 2 |
| EFA | Handpiece, Belt And/Or Gear Driven, Dental | 1 | 1 |
| EFB | Handpiece, Air-Powered, Dental | 1 | 1 |
| EKY | Handpiece, Water-Powered | 1 | 1 |
Review panels
Most recent Saeshin Precision Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251407 | Motor Handpiece and Control Unit (SDI10) | EBW | 2026-01-30 | 269 |
| K233153 | Traus SSG10 Surgical System | HBC | 2024-09-20 | 359 |
| K232938 | Traus SSG30 Surgical System | HBC | 2024-09-16 | 362 |
| K221741 | TRAUS Air Dental Handpiece | EFB | 2023-02-22 | 252 |
| K212043 | TRAUS ENDO | EKX | 2022-06-24 | 359 |
| K201292 | TRAUS SIP20 | EBW | 2021-02-11 | 273 |
| K192561 | TRAUS SUS20 | DZI | 2020-07-13 | 300 |
| K182892 | TRAUS Dental Handpieces | EGS | 2019-11-26 | 407 |
| K181129 | STRONG Dental Handpieces | EGS | 2019-01-31 | 276 |
| K171436 | STRONG Dental Handpieces | EGS | 2018-01-05 | 234 |
8 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Saeshin Precision Co., Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Saeshin Precision Co., Ltd.?
FDA lists 18 510(k) clearances under the applicant name “Saeshin Precision Co., Ltd.” (first 2009, latest 2026), across 8 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Saeshin Precision Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Saeshin Precision Co., Ltd. is 248 days. Since 2017: 288 days, versus 253 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Saeshin Precision Co., Ltd.?
The most frequent FDA product codes under this applicant name are EGS (Handpiece, Contra- And Right-Angle Attachment, Dental, 5); EBW (Controller, Foot, Handpiece And Cord, 3); EKX (Handpiece, Direct Drive, Ac-Powered, 3).
Next steps
- See all 18 Saeshin Precision Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code EGS, Saeshin Precision Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.