Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ossvis Co., Ltd. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
150 daysmedian FDA review time
244 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K242703 | LW Pre-milled Abutment | Ossvis Co., Ltd. | 2024-12-05 | 87 | 0 |
| K242379 | LL Implant System | Ossvis Co., Ltd. | 2024-11-07 | 87 | 0 |
| K233808 | LW Narrow Implant System | Ossvis Co., Ltd. | 2024-07-31 | 244 | 0 |
| K233167 | LW Implant System – Abutment | Ossvis Co., Ltd. | 2024-03-25 | 180 | 0 |
| K231235 | LW UCLA Abutment | Ossvis Co., Ltd. | 2023-09-15 | 140 | 0 |
| K231079 | LW Retraction Cap | Ossvis Co., Ltd. | 2023-09-14 | 150 | 0 |
| K223924 | LW Implant System | Ossvis Co., Ltd. | 2023-08-08 | 221 | 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