Neodental Chemical Products Co., Ltd.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Neodental Chemical Products Co., Ltd.” (first 1996, latest 2011), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 83 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KIF | Resin, Root Canal Filling | 2 | 2 |
| EBG | Crown And Bridge, Temporary, Resin | 1 | 1 |
| EJK | Liner, Cavity, Calcium Hydroxide | 1 | 1 |
| EMA | Cement, Dental | 1 | 1 |
Review panels
- Dental (5)
Most recent Neodental Chemical Products Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K111666 | EVADYNE TEMPORARY CROWN AND BRIDGE RESIN | EBG | 2011-09-07 | 85 |
| K111668 | CAVIOS CAVITY LINER | EJK | 2011-08-19 | 66 |
| K973667 | VITAPEX PRE-LOADED DENTAL SYRINGE | KIF | 1997-11-06 | 42 |
| K971642 | DENTALIS KEZ ENDODONITC SEALER | EMA | 1997-07-24 | 83 |
| K955703 | NEO DENTAL ENDODONTIC IRRIGATION SYRINGE | KIF | 1996-05-20 | 158 |
Recalls
openFDA lists no recalls under a recalling firm named Neodental Chemical Products Co., Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Neodental Chemical Products Co., Ltd.?
FDA lists 5 510(k) clearances under the applicant name “Neodental Chemical Products Co., Ltd.” (first 1996, latest 2011), across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Neodental Chemical Products Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Neodental Chemical Products Co., Ltd. is 83 days.
Which FDA product codes appear under Neodental Chemical Products Co., Ltd.?
The most frequent FDA product codes under this applicant name are KIF (Resin, Root Canal Filling, 2); EBG (Crown And Bridge, Temporary, Resin, 1); EJK (Liner, Cavity, Calcium Hydroxide, 1).
Next steps
- See all 5 Neodental Chemical Products Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code KIF, Neodental Chemical Products Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.