Shofu Dental Corporation
FDA 510(k) & PMA Approved Devices — 23 products
Total Devices23
Categories5
Latest FDA decision2025-12-09
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K252808 | GlasIonomer FX-LC | EMA | 2025-12-09 | View |
| 510(k) | K252165 | ZIRCONOMER P | EMA | 2025-10-28 | View |
| 510(k) | K251470 | ResiCem EX | EMA | 2025-07-11 | View |
| 510(k) | K251578 | BEAUTIFIL II | EBF | 2025-05-27 | View |
| 510(k) | K233161 | BeautiLink SA | EMA | 2023-09-28 | View |
| 510(k) | K222253 | GlasIonomer FX ULTRA | EMA | 2022-09-22 | View |
| 510(k) | K212939 | Vintage Prime Press | EIH | 2022-03-18 | View |
| 510(k) | K213965 | BeautiBond Xtreme | KLE | 2022-03-18 | View |
| 510(k) | K200470 | Shofu Block HC Hard | EBF | 2021-02-05 | View |
| 510(k) | K191794 | Vintage Art Universal | EIH | 2019-10-03 | View |
| 510(k) | K182869 | Fit SA | EBF | 2019-01-09 | View |
| 510(k) | K181496 | VINTAGE PRO | EIH | 2018-12-18 | View |
| 510(k) | K180803 | BeautiBond Universal | KLE | 2018-09-26 | View |
| 510(k) | K180649 | BeautiCem Veneer Kit | EBF | 2018-06-11 | View |
| 510(k) | K172530 | BEAUTIFIL Flow Plus X | EBF | 2017-12-06 | View |
| 510(k) | K172106 | SHOFU MZ Primer Plus | KLE | 2017-08-31 | View |
| 510(k) | K163568 | SHOFU RESIN GLAZE | EBD | 2017-08-16 | View |
| 510(k) | K162261 | CERAMAGE UP | EBF | 2017-01-11 | View |
| 510(k) | K161891 | HC Primer | KLE | 2016-11-21 | View |
| 510(k) | K160596 | BEAUTIFIL II LS | EBF | 2016-07-27 | View |
No matching devices.
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