Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Chengdu Besmile Medical Technology Co., Ltd. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
194 daysmedian FDA review time
354 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252286 | BIORES Dental Implant System | Chengdu Besmile Medical Technology Co., Ltd. | 2026-02-02 | 194 | 0 |
| K242768 | Customized Abutment and Screw | Chengdu Besmile Medical Technology Co., Ltd. | 2025-09-02 | 354 | 0 |
| K232682 | Pre-Sintered Zirconia Coloring Liquid | Chengdu Besmile Medical Technology Co., Ltd. | 2024-03-19 | 200 | 0 |
| K232673 | Dental Glass Ceramics | Chengdu Besmile Medical Technology Co., Ltd. | 2024-01-23 | 144 | 0 |
| K232676 | Dental Porcelain Powder | Chengdu Besmile Medical Technology Co., Ltd. | 2024-01-23 | 144 | 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