Kuraray America, Inc.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Kuraray America, Inc.” (first 1997, latest 2011), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 60 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 |
|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | 5 | 5 |
| KLE | Agent, Tooth Bonding, Resin | 3 | 3 |
| EMA | Cement, Dental | 2 | 2 |
| EBD | Coating, Filling Material, Resin | 1 | 1 |
Review panels
- Dental (11)
Most recent Kuraray America, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K111982 | CLEARFIL DC CORE PLUS | EBF | 2011-11-17 | 128 |
| K111980 | CLEARFIL TRI-S BOND PLUS | KLE | 2011-10-14 | 94 |
| K063595 | CLEARFIL MAJESTY POSTERIOR | EBF | 2007-02-09 | 67 |
| K063593 | CLEARFIL MAJESTY FLOW | EBF | 2007-02-02 | 60 |
| K063228 | SURFACE COAT | EBD | 2006-12-08 | 44 |
| K002322 | MODIFICATION TO PANAVIA F | EMA | 2000-09-18 | 49 |
| K983361 | PANAVIA F | EMA | 1998-11-13 | 50 |
| K982259 | CHROMA ZONE COLOR STAIN | EBF | 1998-09-22 | 88 |
| K982164 | ESTENIA | EBF | 1998-08-10 | 52 |
| K974486 | CLEARFIL LINER BOND 2V | KLE | 1998-01-29 | 64 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Kuraray America, Inc..
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 Company, Ltd. (10 510(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 America, Inc.?
FDA lists 11 510(k) clearances under the applicant name “Kuraray America, Inc.” (first 1997, 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 Kuraray America, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Kuraray America, Inc. is 60 days.
Which FDA product codes appear under Kuraray America, Inc.?
The most frequent FDA product codes under this applicant name are EBF (Material, Tooth Shade, Resin, 5); KLE (Agent, Tooth Bonding, Resin, 3); EMA (Cement, Dental, 2).
Next steps
- See all 11 Kuraray America, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EBF, Kuraray America, Inc.'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.