Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Hangzhou SHINING3D Dental Technology Co., Ltd. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
1 daysmedian FDA review time
3 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261356 | Dura-Crown | Hangzhou SHINING3D Dental Technology Co., Ltd. | 2026-04-27 | 3 | 0 |
| K261261 | Dura-Arch | Hangzhou SHINING3D Dental Technology Co., Ltd. | 2026-04-17 | 1 | 0 |
| K260170 | LumiCera | Hangzhou SHINING3D Dental Technology Co., Ltd. | 2026-01-21 | 1 | 0 |
| K253053 | Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1) | Hangzhou SHINING3D Dental Technology Co., Ltd. | 2025-09-23 | 1 | 0 |
| K250946 | Denture Base Resin DT20 | Hangzhou SHINING3D Dental Technology Co., Ltd. | 2025-03-31 | 3 | 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