Data / Medical devices / Japan / Shofu Inc.
Shofu Inc.: FDA-registered device maker in FUKUINE, HIGASHIYAMA-KU Kyoto, Japan, 67 510(k) clearances
Shofu Inc. is registered with the FDA (registration 3002808149) in FUKUINE, HIGASHIYAMA-KU Kyoto, Japan. It lists 22 device types. The FDA files 67 510(k) clearances under its listings, the newest dated December 9, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3002808149
- Address
- 11 Kamitakamatsu-Cho, FUKUINE, HIGASHIYAMA-KU Kyoto, Japan, 605-0983
- Owner or operator
- SHOFU INC. (9056340)
- Roles
- Exporter to the US, Manufacturer, Repackager or relabeler
- First device listed
- June 5, 1978
- Registered through
- 2027
- Brand names listed
- ACRYLIC KIT HP, ACRYLIC POLISHING KIT, ACRYLIC POLISHING KIT HP, ACRYPOINT, AMALGAM & ALLOY POLISHING KIT CA, AMALGAM & ALLOY POLISHING KIT FG, AMALGAM & METALS KIT CA, AMALGAM & METALS KIT FG and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 9, 2025 | K252808 | GlasIonomer FX-LC | EMA | Substantially Equivalent | Shofu Dental Corporation | accessdata.fda.gov |
| October 28, 2025 | K252165 | ZIRCONOMER P | EMA | Substantially Equivalent | Shofu Dental Corporation | accessdata.fda.gov |
| July 11, 2025 | K251470 | ResiCem EX | EMA | Substantially Equivalent | Shofu Dental Corporation | accessdata.fda.gov |
| September 28, 2023 | K233161 | BeautiLink SA | EMA | Substantially Equivalent | Shofu Dental Corporation | accessdata.fda.gov |
| September 22, 2022 | K222253 | GlasIonomer FX ULTRA | EMA | Substantially Equivalent | Shofu Dental Corporation | accessdata.fda.gov |
| March 18, 2022 | K213965 | BeautiBond Xtreme | KLE | Substantially Equivalent | Shofu Dental Corporation | accessdata.fda.gov |
| March 18, 2022 | K212939 | Vintage Prime Press | EIH | Substantially Equivalent | Shofu Dental Corporation | accessdata.fda.gov |
| October 3, 2019 | K191794 | Vintage Art Universal | EIH | Substantially Equivalent | Shofu Dental Corporation | accessdata.fda.gov |
| January 9, 2019 | K182869 | Fit SA | EBF | Substantially Equivalent | Shofu Dental Corporation | accessdata.fda.gov |
| December 18, 2018 | K181496 | VINTAGE PRO | EIH | Substantially Equivalent | Shofu Dental Corporation | accessdata.fda.gov |
| September 26, 2018 | K180803 | BeautiBond Universal | KLE | Substantially Equivalent | Shofu Dental Corporation | accessdata.fda.gov |
| June 11, 2018 | K180649 | BeautiCem Veneer Kit | EBF | Substantially Equivalent | Shofu Dental Corporation | accessdata.fda.gov |
| December 6, 2017 | K172530 | BEAUTIFIL Flow Plus X | EBF | Substantially Equivalent | Shofu Dental Corporation | accessdata.fda.gov |
| August 31, 2017 | K172106 | SHOFU MZ Primer Plus | KLE | Substantially Equivalent | Shofu Dental Corporation | accessdata.fda.gov |
| August 16, 2017 | K163568 | SHOFU RESIN GLAZE | EBD | Substantially Equivalent | Shofu Dental Corporation | accessdata.fda.gov |
| January 11, 2017 | K162261 | CERAMAGE UP | EBF | Substantially Equivalent | Shofu Dental Corporation | accessdata.fda.gov |
| November 21, 2016 | K161891 | HC Primer | KLE | Substantially Equivalent | Shofu Dental Corporation | accessdata.fda.gov |
| October 19, 2016 | K160203 | ADAMANT ZIRCONIA DISC | EIH | Substantially Equivalent | Adamant Co., Ltd. | accessdata.fda.gov |
| July 27, 2016 | K160596 | BEAUTIFIL II LS | EBF | Substantially Equivalent | Shofu Dental Corporation | accessdata.fda.gov |
| July 21, 2016 | K160086 | SHOFU Enamel Conditioner | EBF | Substantially Equivalent | Shofu Dental Corporation | accessdata.fda.gov |
| March 2, 2016 | K151700 | BEAUTIFIL II Gingiva | EBF | Substantially Equivalent | Shofu Dental Corporation | accessdata.fda.gov |
| January 8, 2016 | K152392 | VINTAGE LD | EIH | Substantially Equivalent | Shofu Dental Corporation | accessdata.fda.gov |
| December 11, 2015 | K152451 | VINTAGE Art LF | EIH | Substantially Equivalent | Shofu Dental Corporation | accessdata.fda.gov |
| December 10, 2015 | K151699 | BEAUTIFIL II Enamel | EBF | Substantially Equivalent | Shofu Dental Corporation | accessdata.fda.gov |
| December 4, 2013 | K132748 | BEAUTIFIL E POSTERIOR, BEAUTIFIL BULK | EBF | Substantially Equivalent | Shofu Dental Corporation | accessdata.fda.gov |
| October 3, 2013 | K132141 | BEAUTIFIL BULK FLOWABLE | EBF | Substantially Equivalent | Shofu Dental Corporation | accessdata.fda.gov |
| September 11, 2013 | K130841 | SHOFU BLOCK HC | EBF | Substantially Equivalent | Shofu Dental Corporation | accessdata.fda.gov |
| July 16, 2013 | K131504 | UNIVERSAL OPAQUE | EBF | Substantially Equivalent | Shofu Dental Corporation | accessdata.fda.gov |
| May 16, 2013 | K122614 | VINTAGE MP PRESS OVER | EIH | Substantially Equivalent | Shofu Dental Corporation | accessdata.fda.gov |
| April 26, 2013 | K122908 | PRG BARRIER COAT | LBH | Substantially Equivalent | Shofu Dental Corporation | accessdata.fda.gov |
| November 28, 2012 | K123119 | CERARESIN BOND | KLE | Substantially Equivalent | Shofu Dental Corporation | accessdata.fda.gov |
| September 7, 2012 | K121749 | VERACIA | ELM | Substantially Equivalent | Shofu Dental Corporation | accessdata.fda.gov |
| June 18, 2012 | K120159 | BEAUTICEM SA | EMA | Substantially Equivalent | Shofu Dental Corporation | accessdata.fda.gov |
| February 8, 2012 | K113426 | VERACIA SA | ELM | Substantially Equivalent | Shofu Dental Corporation | accessdata.fda.gov |
| November 17, 2011 | K111855 | HY-BOND RESIGLASS | EMA | Substantially Equivalent | Shofu Dental Corp. | accessdata.fda.gov |
| September 16, 2011 | K111782 | BEAUTISEALANT | EBC | Substantially Equivalent | Shofu Dental Corporation | accessdata.fda.gov |
| September 2, 2011 | K111685 | IP TEMP CEMENT | EMA | Substantially Equivalent | Shofu Dental Corporation | accessdata.fda.gov |
| August 23, 2010 | K101621 | LITE ART | EBF | Substantially Equivalent | Shofu Dental Corp. | accessdata.fda.gov |
| August 23, 2010 | K101603 | BEAUTIFIL FLOW PLUS | EBF | Substantially Equivalent | Shofu Dental Corp. | accessdata.fda.gov |
| March 3, 2010 | K093559 | VINTAGE MP | EIH | Substantially Equivalent | Shofu Dental Corp. | accessdata.fda.gov |
| December 11, 2008 | K082744 | BEAUTIBOND | KLE | Substantially Equivalent | Shofu Dental Corp. | accessdata.fda.gov |
| June 11, 2008 | K080834 | VINTAGE ART | EIH | Substantially Equivalent | Shofu Dental Corp. | accessdata.fda.gov |
| June 11, 2008 | K080517 | RESICEM | EMA | Substantially Equivalent | Shofu Dental Corp. | accessdata.fda.gov |
| February 28, 2008 | K080068 | BEAUTIFIL OPAQUER | EBF | Substantially Equivalent | Shofu Dental Corp. | accessdata.fda.gov |
| August 15, 2007 | K071742 | BEAUTIFIL II | EBF | Substantially Equivalent | Shofu Dental Corp. | accessdata.fda.gov |
| July 9, 2007 | K071452 | FL BOND II | KLE | Substantially Equivalent | Shofu Dental Corp. | accessdata.fda.gov |
| November 18, 2005 | K052033 | VINTAGE ZR | EIH | Substantially Equivalent | Shofu Dental Corp. | accessdata.fda.gov |
| August 3, 2005 | K051818 | BEAUTIFIL FLOW | EBF | Substantially Equivalent | Shofu Dental Corp. | accessdata.fda.gov |
| April 28, 2005 | K050401 | CERAMAGE | EBF | Substantially Equivalent | Shofu Dental Corp. | accessdata.fda.gov |
| September 9, 2004 | K040079 | M.L. PRIMER | KLE | Substantially Equivalent | Shofu Dental Corp. | accessdata.fda.gov |
| February 5, 2004 | K032416 | VINTAGE PRESS, VINTAGE LF, VINTAGE LF STAIN | EIH | Substantially Equivalent | Shofu Dental Corp. | accessdata.fda.gov |
| September 16, 2003 | K032165 | VINTAGE AL | EIH | Substantially Equivalent | Shofu Dental Corp. | accessdata.fda.gov |
| July 17, 2003 | K031467 | GLASIONOMER FX-II | EMA | Substantially Equivalent | Shofu Dental Corp. | accessdata.fda.gov |
| April 20, 2001 | K010914 | BEAUTIFIL | EBF | Substantially Equivalent | Shofu Dental Corp. | accessdata.fda.gov |
| September 26, 2000 | K002461 | HY-BOND POLYCARBOXYLATE TEMPORARY DENTAL CEMENT | EMA | Substantially Equivalent | Shofu Dental Corp. | accessdata.fda.gov |
| August 24, 1998 | K982461 | GLASIONOMER CEMENT CX PLUS | EMA | Substantially Equivalent | Shofu Dental Corp. | accessdata.fda.gov |
| October 29, 1997 | K972292 | SOLIDEX | EBF | Substantially Equivalent | Shofu Dental Corp. | accessdata.fda.gov |
| October 16, 1997 | K973247 | VINTAGE HALO | EIH | Substantially Equivalent | Shofu Dental Corp. | accessdata.fda.gov |
| September 24, 1996 | K962542 | AIR MOTOR HANDPIECE TN-102 | EFB | Substantially Equivalent | Nsk Nakanishi, Inc. | accessdata.fda.gov |
| July 14, 1989 | K893481 | CRYSTAR(TM) ANTI-GREENING LIQUID | ELL | Substantially Equivalent | Shofu Dental Corp. | accessdata.fda.gov |
| December 8, 1988 | K884214 | CRYSTAR(TM) VINTAGE PORCELAIN | ELL | Substantially Equivalent | Shofu Dental Corp. | accessdata.fda.gov |
| April 25, 1986 | K861005 | GLASIONOMER BASE CEMENT | EMA | Substantially Equivalent | Shofu Dental Corp. | accessdata.fda.gov |
| April 10, 1985 | K850913 | GLAS IONOMER CEMENT | EMA | Substantially Equivalent | Shofu Dental Corp. | accessdata.fda.gov |
| May 11, 1984 | K841196 | HY-BOND ZINC OXIDE EUGENOL TEMP. | EMA | Substantially Equivalent | Shofu Dental Corp. | accessdata.fda.gov |
| March 6, 1984 | K834497 | SHOFU PORCELAIN STAIN | EIH | Substantially Equivalent | Shofu Dental Corp. | accessdata.fda.gov |
| June 12, 1981 | K810765 | HY-BOND ZINC PHOSPHATE CEMENT | EMA | Substantially Equivalent | Shofu Dental Corp. | accessdata.fda.gov |
| June 12, 1981 | K810764 | HY-BOND POLYCARBOXYLATE CEMENT | EMA | Substantially Equivalent | Shofu Dental Corp. | accessdata.fda.gov |
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Updated December 9, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.