Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Vatech Acucera, Inc. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K222686 | Perfit FS Dental Zirconia Fully Sintered Block | Vatech Acucera, Inc. | 2022-10-06 | 30 | 0 |
| K203590 | Perfit FS Dental Zirconia Fully Sintered Block | Vatech Acucera, Inc. | 2021-06-24 | 198 | 0 |
| K203499 | Perfit ZR ST Dental Zirconia blank, Perfit ZR UT Dental Zirc | Vatech Acucera, Inc. | 2021-04-05 | 129 | 0 |
| K203351 | Perfit ZR HT Dental Zirconia blank | Vatech Acucera, Inc. | 2021-03-08 | 115 | 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