Kuraray Medical, Inc.: FDA filings under this applicant name
FDA lists 42 510(k) clearances under the applicant name “Kuraray Medical, Inc.” (first 2001, latest 2012), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 38 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 | 2 | 52 |
| 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 | 18 | 18 |
| KLE | Agent, Tooth Bonding, Resin | 14 | 14 |
| EMA | Cement, Dental | 8 | 8 |
| EBC | Sealant, Pit And Fissure, And Conditioner | 1 | 1 |
| LFC | Device, Caries Detection | 1 | 1 |
Review panels
- Dental (42)
Most recent Kuraray Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K120379 | PANAVIA SA CEMENT AUTOMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA CEMENT AUTOMIX (UNIVERSAL (A2), WHITE) PANAVIA S | EMA | 2012-03-30 | 52 |
| K120378 | PANAVIA SA CEMENT HANDMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA CEMENT HANDMIX (UNIVERSAL (A2), WHITE) PANAVIA S | EMA | 2012-03-30 | 52 |
| K111975 | CLEARFIL TRI-S BOND PLUS SINGLE DOSE STANDARD / VALUE / INTRODUCTORY PACK | KLE | 2011-10-14 | 94 |
| K100328 | CLEARFIL MAJETY POSTERIOR | EBF | 2010-03-05 | 29 |
| K092281 | CLEARFIL MAJESTY POSTERIOR PLT | EBF | 2009-10-27 | 90 |
| K081583 | CLEARFIL SA CEMENT | EMA | 2008-07-28 | 53 |
| K071169 | CLEARFIL MAJESTY POSTERIOR PLT | EBF | 2007-06-20 | 54 |
| K070325 | CLEARFIL MAJESTY ESTHETIC PLT | EBF | 2007-03-21 | 44 |
| K062409 | K-ETCHANT GEL | EBF | 2006-11-08 | 83 |
| K061906 | CLEARFIL CERAMIC PRIMER | EBF | 2006-09-28 | 85 |
32 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Kuraray Medical, 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 Noritake Dental, Inc. (32 510(k)s)
- Kuraray Co. (25 510(k)s)
- Kuraray America, Inc. (11 510(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 Medical, Inc.?
FDA lists 42 510(k) clearances under the applicant name “Kuraray Medical, Inc.” (first 2001, latest 2012), across 5 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 Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Kuraray Medical, Inc. is 38 days.
Which FDA product codes appear under Kuraray Medical, Inc.?
The most frequent FDA product codes under this applicant name are EBF (Material, Tooth Shade, Resin, 18); KLE (Agent, Tooth Bonding, Resin, 14); EMA (Cement, Dental, 8).
Next steps
- See all 42 Kuraray Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EBF, Kuraray Medical, 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.