Shofu Dental Corporation
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 38
- Inspections
- 2
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K252808 | GlasIonomer FX-LC | December 9, 2025 |
| K252165 | ZIRCONOMER P | October 28, 2025 |
| K251470 | ResiCem EX | July 11, 2025 |
| K251578 | BEAUTIFIL II | May 27, 2025 |
| K233161 | BeautiLink SA | September 28, 2023 |
| K222253 | GlasIonomer FX ULTRA | September 22, 2022 |
| K212939 | Vintage Prime Press | March 18, 2022 |
| K213965 | BeautiBond Xtreme | March 18, 2022 |
| K200470 | Shofu Block HC Hard | February 5, 2021 |
| K191794 | Vintage Art Universal | October 3, 2019 |
| K182869 | Fit SA | January 9, 2019 |
| K181496 | VINTAGE PRO | December 18, 2018 |
| K180803 | BeautiBond Universal | September 26, 2018 |
| K180649 | BeautiCem Veneer Kit | June 11, 2018 |
| K172530 | BEAUTIFIL Flow Plus X | December 6, 2017 |
| K172106 | SHOFU MZ Primer Plus | August 31, 2017 |
| K163568 | SHOFU RESIN GLAZE | August 16, 2017 |
| K162261 | CERAMAGE UP | January 11, 2017 |
| K161891 | HC Primer | November 21, 2016 |
| K160596 | BEAUTIFIL II LS | July 27, 2016 |