Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Saeshin Precision Co., Ltd. — Predicate Candidate Screening
18 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
252 daysmedian FDA review time
362 days90th percentile
18clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251407 | Motor Handpiece and Control Unit (SDI10) | Saeshin Precision Co., Ltd. | 2026-01-30 | 269 | 0 |
| K233153 | Traus SSG10 Surgical System | Saeshin Precision Co., Ltd. | 2024-09-20 | 359 | 0 |
| K232938 | Traus SSG30 Surgical System | Saeshin Precision Co., Ltd. | 2024-09-16 | 362 | 0 |
| K221741 | TRAUS Air Dental Handpiece | Saeshin Precision Co., Ltd. | 2023-02-22 | 252 | 0 |
| K212043 | TRAUS ENDO | Saeshin Precision Co., Ltd. | 2022-06-24 | 359 | 0 |
| K201292 | TRAUS SIP20 | Saeshin Precision Co., Ltd. | 2021-02-11 | 273 | 0 |
| K192561 | TRAUS SUS20 | Saeshin Precision Co., Ltd. | 2020-07-13 | 300 | 0 |
| K182892 | TRAUS Dental Handpieces | Saeshin Precision Co., Ltd. | 2019-11-26 | 407 | 0 |
| K181129 | STRONG Dental Handpieces | Saeshin Precision Co., Ltd. | 2019-01-31 | 276 | 0 |
| K171436 | STRONG Dental Handpieces | Saeshin Precision Co., Ltd. | 2018-01-05 | 234 | 0 |
| K151171 | TRAUS SUS10 | Saeshin Precision Co., Ltd. | 2015-09-01 | 123 | 0 |
| K143418 | STRONG Dental Handpieces | Saeshin Precision Co., Ltd. | 2015-07-31 | 245 | 0 |
| K143411 | TRAUS ENDO | Saeshin Precision Co., Ltd. | 2015-06-29 | 213 | 0 |
| K123695 | TRAUS SIP10 | Saeshin Precision Co., Ltd. | 2012-12-18 | 15 | 0 |
| K111616 | E-CUBE | Saeshin Precision Co., Ltd. | 2011-08-19 | 70 | 0 |
| K100192 | STRONG DENTAL HANDPIECES | Saeshin Precision Co., Ltd. | 2010-02-04 | 13 | 0 |
| K092758 | X-CUBE | Saeshin Precision Co., Ltd. | 2009-09-21 | 12 | 0 |
| K092412 | STRONG IMPLANT HANDPIECES | Saeshin Precision Co., Ltd. | 2009-09-03 | 28 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda