Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Codent Technical Industry Co., Ltd. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
127 daysmedian FDA review time
389 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K231864 | Fiber Optic Brushless Electronic Micromotor, model: iM100 | Codent Technical Industry Co., Ltd. | 2024-03-11 | 259 | 0 |
| K152146 | High Speed Handpieces and Accessories | Codent Technical Industry Co., Ltd. | 2015-12-08 | 127 | 0 |
| K150798 | Codent Low Speed Dental Handpieces and Accessories | Codent Technical Industry Co., Ltd. | 2015-04-24 | 29 | 0 |
| K133069 | CODENT LOW SPEED DENTAL HANDPIECES AND ACCESSORIES | Codent Technical Industry Co., Ltd. | 2014-10-24 | 389 | 0 |
| K033213 | CODENT DENTAL AIR-POWERED HANDPIECE, MODEL HPS | Codent Technical Industry Co., Ltd. | 2004-02-06 | 126 | 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