Kuraray Company, Ltd.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Kuraray Company, Ltd.” (first 1994, latest 2000), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 40 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 |
|---|---|---|---|
| KLE | Agent, Tooth Bonding, Resin | 5 | 5 |
| EBF | Material, Tooth Shade, Resin | 3 | 3 |
| EBC | Sealant, Pit And Fissure, And Conditioner | 1 | 1 |
| EMA | Cement, Dental | 1 | 1 |
Review panels
- Dental (10)
Most recent Kuraray Company, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K001914 | CLEARFIL REPAIR | KLE | 2000-08-10 | 48 |
| K001913 | CLEARFIL ST OPAQUER | EBF | 2000-08-04 | 42 |
| K980232 | CLEARFIL DC CEMENT | EMA | 1998-02-24 | 33 |
| K965091 | TEETHMATE F-1 | EBC | 1997-03-27 | 98 |
| K943170 | CLEARFIL LINER BOND 2 | KLE | 1994-08-10 | 40 |
| K943169 | CLEARFIL AP-X AND LINER BOND 2 | EBF | 1994-08-10 | 40 |
| K943168 | CLEARFIL AP-X | EBF | 1994-08-10 | 40 |
| K943167 | CLEARFIL NEW BOND | KLE | 1994-08-10 | 40 |
| K943166 | CLEARFIL LINER BOND SYSTEM | KLE | 1994-08-10 | 40 |
| K943165 | CLEARFIL PHOTO BOND | KLE | 1994-08-10 | 40 |
Recalls
openFDA lists no recalls under a recalling firm named Kuraray Company, 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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Kuraray Medical, Inc. (42 510(k)s)
- Kuraray Noritake Dental, Inc. (32 510(k)s)
- Kuraray Co. (25 510(k)s)
- Kuraray America, Inc. (11 510(k)s)
- Kuraray Medical Kurashiki Plant (2 510(k)s)
- Kuraray Intl. Corp. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Kuraray Company, Ltd.?
FDA lists 10 510(k) clearances under the applicant name “Kuraray Company, Ltd.” (first 1994, latest 2000), 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 Kuraray Company, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Kuraray Company, Ltd. is 40 days.
Which FDA product codes appear under Kuraray Company, Ltd.?
The most frequent FDA product codes under this applicant name are KLE (Agent, Tooth Bonding, Resin, 5); EBF (Material, Tooth Shade, Resin, 3); EBC (Sealant, Pit And Fissure, And Conditioner, 1).
Next steps
- See all 10 Kuraray Company, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code KLE, Kuraray Company, 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.