Shofu Dental Corp.: FDA filings under this applicant name
FDA lists 97 510(k) clearances under the applicant name “Shofu Dental Corp.” (first 1981, latest 2025), across 16 product codes in 2 review panels. Median 510(k) review time under this name: 78 days. Since 2017 the median was 94 days, against 119 days for all cleared 510(k)s in the same product codes. 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 | 5 | 85 |
| 2013 | 6 | 130 |
| 2014 | 0 | — |
| 2015 | 2 | 137 |
| 2016 | 5 | 147 |
| 2017 | 4 | 130 |
| 2018 | 3 | 182 |
| 2019 | 2 | 90 |
| 2020 | 0 | — |
| 2021 | 1 | 345 |
| 2022 | 3 | 88 |
| 2023 | 1 | 1 |
| 2024 | 0 | — |
| 2025 | 4 | 78 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Shofu Dental Corp. took a median 94 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 119 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | 27 | 27 |
| EMA | Cement, Dental | 24 | 24 |
| EIH | Powder, Porcelain | 15 | 15 |
| KLE | Agent, Tooth Bonding, Resin | 13 | 13 |
| DZP | Instrument, Diamond, Dental | 4 | 4 |
| EJH | Alloy, Metal, Base | 2 | 2 |
| ELL | Teeth, Porcelain | 2 | 2 |
| ELM | Denture, Plastic, Teeth | 2 | 2 |
| EBC | Sealant, Pit And Fissure, And Conditioner | 1 | 1 |
| EBD | Coating, Filling Material, Resin | 1 | 1 |
Plus 6 more product codes.
Review panels
- Dental (96)
- Obstetrics and Gynecology (1)
Most recent Shofu Dental Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252808 | GlasIonomer FX-LC | EMA | 2025-12-09 | 97 |
| K252165 | ZIRCONOMER P | EMA | 2025-10-28 | 110 |
| K251470 | ResiCem EX | EMA | 2025-07-11 | 59 |
| K251578 | BEAUTIFIL II | EBF | 2025-05-27 | 5 |
| K233161 | BeautiLink SA | EMA | 2023-09-28 | 1 |
| K222253 | GlasIonomer FX ULTRA | EMA | 2022-09-22 | 57 |
| K213965 | BeautiBond Xtreme | KLE | 2022-03-18 | 88 |
| K212939 | Vintage Prime Press | EIH | 2022-03-18 | 184 |
| K200470 | Shofu Block HC Hard | EBF | 2021-02-05 | 345 |
| K191794 | Vintage Art Universal | EIH | 2019-10-03 | 92 |
87 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Shofu Dental Corp..
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 Shofu Dental Corp.?
FDA lists 97 510(k) clearances under the applicant name “Shofu Dental Corp.” (first 1981, latest 2025), across 16 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Shofu Dental Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Shofu Dental Corp. is 78 days. Since 2017: 94 days, versus 119 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Shofu Dental Corp.?
The most frequent FDA product codes under this applicant name are EBF (Material, Tooth Shade, Resin, 27); EMA (Cement, Dental, 24); EIH (Powder, Porcelain, 15).
Next steps
- See all 97 Shofu Dental Corp. clearances with predicates and recalls
- Run predicate analysis for product code EBF, Shofu Dental Corp.'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.