Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Neodental Chemical Products Co., Ltd. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
83 daysmedian FDA review time
158 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K111666 | EVADYNE TEMPORARY CROWN AND BRIDGE RESIN | Neodental Chemical Products Co., Ltd. | 2011-09-07 | 85 | 0 |
| K111668 | CAVIOS CAVITY LINER | Neodental Chemical Products Co., Ltd. | 2011-08-19 | 66 | 0 |
| K973667 | VITAPEX PRE-LOADED DENTAL SYRINGE | Neodental Chemical Products Co., Ltd. | 1997-11-06 | 42 | 0 |
| K971642 | DENTALIS KEZ ENDODONITC SEALER | Neodental Chemical Products Co., Ltd. | 1997-07-24 | 83 | 0 |
| K955703 | NEO DENTAL ENDODONTIC IRRIGATION SYRINGE | Neodental Chemical Products Co., Ltd. | 1996-05-20 | 158 | 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