Medical Device Manufacturer · US , San Marcos , CA

Shofu Dental Corporation

38 submissions · 38 cleared · Since 2011
38
Total
38
Cleared
0
Denied

Shofu Dental Corporation — FDA 510(k) Submissions

Shofu Dental Corporation has submitted 38 FDA 510(k) premarket notifications since 2011, of which 38 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Material, Tooth Shade, Resin, Cement, Dental, Powder, Porcelain, Agent, Tooth Bonding, Resin, Denture, Plastic, Teeth . Use the specialty filter in the sidebar to narrow results.

38 devices
1–25 of 38
GlasIonomer FX-LC
K252808 · EMA Cement, Dental · Dental
Dec 2025 97d
ZIRCONOMER P
K252165 · EMA Cement, Dental · Dental
Oct 2025 110d
ResiCem EX
K251470 · EMA Cement, Dental · Dental
Jul 2025 59d
BEAUTIFIL II
K251578 · EBF Material, Tooth Shade, Resin · Dental
May 2025 5d
BeautiLink SA
K233161 · EMA Cement, Dental · Dental
Sep 2023 1d
GlasIonomer FX ULTRA
K222253 · EMA Cement, Dental · Dental
Sep 2022 57d
Vintage Prime Press
K212939 · EIH Powder, Porcelain · Dental
Mar 2022 184d
BeautiBond Xtreme
K213965 · KLE Agent, Tooth Bonding, Resin · Dental
Mar 2022 88d
Shofu Block HC Hard
K200470 · EBF Material, Tooth Shade, Resin · Dental
Feb 2021 345d
Vintage Art Universal
K191794 · EIH Powder, Porcelain · Dental
Oct 2019 92d
Fit SA
K182869 · EBF Material, Tooth Shade, Resin · Dental
Jan 2019 89d
VINTAGE PRO
K181496 · EIH Powder, Porcelain · Dental
Dec 2018 194d
BeautiBond Universal
K180803 · KLE Agent, Tooth Bonding, Resin · Dental
Sep 2018 182d
BeautiCem Veneer Kit
K180649 · EBF Material, Tooth Shade, Resin · Dental
Jun 2018 90d
BEAUTIFIL Flow Plus X
K172530 · EBF Material, Tooth Shade, Resin · Dental
Dec 2017 107d
SHOFU MZ Primer Plus
K172106 · KLE Agent, Tooth Bonding, Resin · Dental
Aug 2017 50d
SHOFU RESIN GLAZE
K163568 · EBD Coating, Filling... · Dental
Aug 2017 240d
CERAMAGE UP
K162261 · EBF Material, Tooth Shade, Resin · Dental
Jan 2017 153d
HC Primer
K161891 · KLE Agent, Tooth Bonding, Resin · Dental
Nov 2016 133d
BEAUTIFIL II LS
K160596 · EBF Material, Tooth Shade, Resin · Dental
Jul 2016 147d
SHOFU Enamel Conditioner
K160086 · EBF Material, Tooth Shade, Resin · Dental
Jul 2016 188d
BEAUTIFIL II Gingiva
K151700 · EBF Material, Tooth Shade, Resin · Dental
Mar 2016 252d
VINTAGE LD
K152392 · EIH Powder, Porcelain · Dental
Jan 2016 137d
VINTAGE Art LF
K152451 · EIH Powder, Porcelain · Dental
Dec 2015 105d
BEAUTIFIL II Enamel
K151699 · EBF Material, Tooth Shade, Resin · Dental
Dec 2015 169d
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