Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Shofu Dental Corporation

FDA 510(k) & PMA Approved Devices — 23 products

Total Devices23
Categories5
Latest Approval2025-12-09
TypeNumberDevice NameCodeDate
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
510(k) K160086 SHOFU Enamel Conditioner EBF 2016-07-21 View
510(k) K151700 BEAUTIFIL II Gingiva EBF 2016-03-02 View
510(k) K152392 VINTAGE LD EIH 2016-01-08 View
↑