Manufacturer registered with FDA
Shofu Inc
KYOTO, Japan. Lists 25 dental device types with FDA across 6 registered establishments, and holds 96 510(k) clearances as applicant.
- Device types listed
- 25
- Brands and models
- 174
- 510(k) clearances
- 961981–2025
- Markets registered in
- 15831 registrations outside the US
- Establishments
- 6China, Japan, United States +1
510(k) clearances per year, 1980–2026
Registered in 15 markets
Where regulators' registries name Shofu Inc as the manufacturer or the registration holder of a device.
RegisteredHome: JapanOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Shofu Inc | 96 clearances | 1981–2025 | Below |
| Canada | Health Canada | Registration holder | SHOFU INC.SHOFU DENTAL CORPORATION | 233 | 2003–2026 | Pure Global AI |
| Colombia | INVIMA | Registration holder | SHOFU DENTAL CORPORATION.SHOFU DENTAL CORPORATION · SHOFU INC. · +2 | 166 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | SHOFU INC.SHIGA SHOFU INC. · SHOFU,INC · +2 | 124 | 1998–2026 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | SHOFU INC.SHIGA SHOFU INC. · SHANGHAI SHOFU DENTAL MATERIAL CO., LTD. · +2 | 87 | 2005–2025 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | SHOFU INC.SHANGHAI SHOFU DENTAL MATERIAL CO. LTD | 63 | 2003–2026 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | SHOFU INC. | 55 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | SHOFU INC. | 32 | 2024–2024 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | SHOFU INC.SHANGHAI SHOFU DENTAL MATERIAL CO., LTD. · SHIGA SHOFU INC | 20 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | SHOFU INCSHOFU INC. | 18 | 2014–2026 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | SHOFU INC | 10 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Shofu Inc | 8 | 2020–2026 | Pure Global AI |
| China | NMPA | Registration holder | 株式会社松风SHOFU INC.株式会社松风SHOFU INC.（株式会社松風） · 株式会社松風 SHOFU INC. | 7 | — | Pure Global AI |
| Hong Kong | MDD | Manufacturer | SHOFU INC. | 6 | 2025–2026 | Pure Global AI |
| Israel | AMAR | Manufacturer | SHOFU INC. | 2 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Shofu Inc currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Resin Tooth Shade MaterialEBF · Class 2 | Dental composites | Maker | BEAUTICEM VENEER KITBEAUTIFILBEAUTIFIL BULKBEAUTIFIL BULK FLOWABLEBEAUTIFIL E POSTERIORBEAUTIFIL FLOWBEAUTIFIL FLOW PLUSBEAUTIFIL FLOW PLUS XBEAUTIFIL IIBEAUTIFIL II Enamel 22 moreBEAUTIFIL II GingivaBeautifil II Gingiva PINK & Enamel WHITE KitBEAUTIFIL II Gingiva Pink KitBEAUTIFIL II LSBEAUTIFIL KIDS SABEAUTIFIL OPAQUERCERAMAGECERAMAGE UPCLASS V PROCEDURE KITCLEAR ALIGNER PROCEDURE KITFIT SALITE ARTSHOFU BLOCK HCSHOFU BLOCK HC HARDSHOFU DISK HCSHOFU ENAMEL CONDITIONERSolidexSOLIDILITE LEDSOLIDILITE VTRINIAUNIVERSAL OPAQUEUNIVERSAL OXYBARRIER | 2008 |
| Dental CementEMA · Class 2 | Dental cements | Maker | AZ PRIMERBEAUTICEM SABEAUTILINK SAFL BOND IIGLASIONOMER BASE CEMENTGLASIONOMER CEMENT CX-PLUSGLASIONOMER FX ULTRAGLASIONOMER FX-IIGLASIONOMER FX-LCGLASIONOMER TYPE II CEMENT 12 moreHY-BOND POLY CEMENTHY-BOND POLY TEMP CEMENTHY-BOND RESIGLASSHY-BOND ZINC OXIDE TEMP CEMENTHY-BOND ZINC PHOSPHATE CEMENTIP TEMP CEMENTMONOCEMPORCELAIN PRIMERRESICEM CEMENTRESICEM EXSHOFU MZ Primer PlusZIRCONOMER P | 2008 |
| Porcelain PowderEIH · Class 2 | Dental ceramics & zirconia | Maker | DENTADISC ZRLAYZIR DISCPORCELAIN STAIN POWDERVINTAGE ALVINTAGE ARTVINTAGE ART LFVINTAGE ART UNIVERSALVINTAGE GUMMY SHADE GUIDEVINTAGE HALOVINTAGE HALO MODEL LIQUID-L 500mL 10 moreVINTAGE HALO MODEL LIQUID-L 50mLVINTAGE HALO OPAQUE LIQUID-L 50mLVINTAGE LDVINTAGE LFVINTAGE MPVINTAGE MP PRESS OVERVINTAGE PRIME PRESSVINTAGE PROVINTAGE ZRVINTAGE ZR UNI-LAYER | 2008 |
| Resin Tooth Bonding AgentKLE · Class 2 | Bonding agents | Maker | BEAUTIBONDBEAUTIBOND UNIVERSALBEAUTIBOND XTREMEBEAUTICEM VENEER KITCeraresin BondFL BOND IIHC PRIMERINCISAL EDGE WEAR KITM.L. PRIMERP&R Repair Kit 1 moreSHOFU MZ Primer Plus | 2008 |
| Resin Temporary Crown and BridgeEBG · Class 2 | Temporary crown & bridge materials | Maker | DENTADISCSHOFU BLOCK HCSHOFU BLOCK HC HARDSHOFU DISK HC | 2013 |
| Abrasive DiskEHJ · Class 1 | Polishing & prophylaxis | Maker | SUPER-SNAP | 1978 |
| Abrasive PointEHL · Class 1 | Polishing & prophylaxis | Maker | ACRYLIC KIT HPACRYLIC POLISHING KITACRYLIC POLISHING KIT HPACRYPOINTAMALGAM & ALLOY POLISHING KIT CAAMALGAM & ALLOY POLISHING KIT FGAMALGAM & METALS KIT CAAMALGAM & METALS KIT FGAMALGAM & METALS POLISHING KIT CAAMALGAM & METALS POLISHING KIT FG 38 moreBROWNIEBURBUTLER ALL CERAMIC ABRASIVE KITBURBUTLER CADMASTER KITCERAMASTERCERAMISTECERAMISTE SOFTCOMPOMASTERCOMPOSITECOMPOSITE KIT CACOMPOSITE POLISHING KIT CACOREMASTERDURA-GREEN FINEDURA-GREEN STONESDURA-WHITE STONESDURAGREENDURAGREEN FINEDURAWHITEGLOSSMASTER ZRGREENIEHARDIELAB CORALLAB PINKLAB WHITEONE GLOSSONE GLOSS PS SAMPLE PACKPINK PREPARATION BUTPORCELAIN & ENAMEL KIT CAPORCELAIN & ENAMEL POLISHING KIT CASUPER SNAP X-TREME SAMPLE PACKSUPER-SNAPSUPER-SNAP SUPERBUFFSUPERBUFFSUPERGREENIESUPERSNAPTHE ATTACHMENT REMOVAL KIT FOR CLEAR ALIGNERSZILMASTERZIRCONIA KIT CAZIRCONIA POLISHING KIT CA | 2003 |
| Teeth Plastic DentureELM · Class 2 | Denture resins & teeth | Maker | VERACIAVERACIA SA | 2012 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | BEAUTIFIL Needle Tips 18GBEAUTIFIL Needle Tips 20GBEAUTIFIL Needle Tips 20G-LBeautiSealant Needle Tips 23GBeautiSealant Needle Tips 27GMICD INSTRUMENTS | 2015 |
| Dental Diamond InstrumentDZP · Class 1 | Dental burs & diamonds | Maker | — | 1978 |
| Resin Filling Material CoatingEBD · Class 2 | — | Maker | SHOFU RESIN GLAZE | 2017 |
| Polishing Agent StripEHM · Class 1 | Polishing & prophylaxis | Maker | SUPER-SNAP IPRSUPER-SNAP POLYSTRIPS | 2021 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | ROBOT CARBIDETHE ARTISTIC COMPOSITE KIT | 1996 |
| ArticulatorsEJP · Class 1 | Articulators & facebows | Maker | HANDY IIMPRO ARCH | 1978 |
| Oral Cavity Abrasive Polishing AgentEJR · Class 1 | Polishing & prophylaxis | Maker | COMPOSITE PASTECOMPOSITE PASTE GERMANYCOMPOSITE POLISHING PASTEDIRECT DIA POLISHING PASTEDIRECTDIASHOFU COMPOSITE POLISHING PASTE | 2007 |
| Porcelain TeethELL · Class 2 | Dental ceramics & zirconia | Maker | ANTI-GREENING LIQUIDVINTAGE PAINT OPAQUE LIQUID - 50mLVINTAGE PORCELAIN | 2008 |
| Resin ApplicatorKXR · Class 1 | — | Maker | PORCELAIN BRUSH ARTPORCELAIN BRUSH ART SETPORCELAIN BRUSH SET ARTUNI BRUSH | 2022 |
| Pit and Fissure Sealant and ConditionerEBC · Class 2 | Sealants & varnishes | Maker | BEAUTISEALANT | 2011 |
| Resin Impression Tray MaterialEBH · Class 1 | Impression trays | Lister | DENTAPRINT | 2025 |
| Rebasing Repairing Relining Denture ResinEBI · Class 2 | Denture resins & teeth | Lister | DENTADISC | 2026 |
| Dental Air-Powered HandpieceEFB · Class 1 | Dental handpieces | Lister | LAB AIR Z HANDPIECE | 2008 |
| Operative Amalgam and Foil CondenserEKG · Class 1 | Dental hand instruments | Maker | Condenser | 2003 |
| Operative Dental Amalgam CarverEKH · Class 1 | Dental hand instruments | Maker | INSTRUMENT, DIAMOND, DENTAL | 2003 |
| Cavity VarnishLBH · Class 2 | Sealants & varnishes | Maker | PRG BARRIER COAT | 2013 |
| Intraoral CameraQJK · Class 2 | Intraoral cameras | Lister | EYECAM | 2020 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Shofu Inc as the applicant, including filings under its other names.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 9 Dec 2025 | K252808 | GlasIonomer FX-LC | EMA Dental Cement |
| 28 Oct 2025 | K252165 | ZIRCONOMER P | EMA Dental Cement |
| 11 Jul 2025 | K251470 | ResiCem EX | EMA Dental Cement |
| 27 May 2025 | K251578 | BEAUTIFIL II | EBF Resin Tooth Shade Material |
| 28 Sep 2023 | K233161 | BeautiLink SA | EMA Dental Cement |
| 22 Sep 2022 | K222253 | GlasIonomer FX ULTRA | EMA Dental Cement |
| 18 Mar 2022 | K213965 | BeautiBond Xtreme | KLE Resin Tooth Bonding Agent |
| 18 Mar 2022 | K212939 | Vintage Prime Press | EIH Porcelain Powder |
| 5 Feb 2021 | K200470 | Shofu Block HC Hard | EBF Resin Tooth Shade Material |
| 3 Oct 2019 | K191794 | Vintage Art Universal | EIH Porcelain Powder |
| 9 Jan 2019 | K182869 | Fit SA | EBF Resin Tooth Shade Material |
| 18 Dec 2018 | K181496 | VINTAGE PRO | EIH Porcelain Powder |
| 26 Sep 2018 | K180803 | BeautiBond Universal | KLE Resin Tooth Bonding Agent |
| 11 Jun 2018 | K180649 | BeautiCem Veneer Kit | EBF Resin Tooth Shade Material |
| 6 Dec 2017 | K172530 | BEAUTIFIL Flow Plus X | EBF Resin Tooth Shade Material |
| 31 Aug 2017 | K172106 | SHOFU MZ Primer Plus | KLE Resin Tooth Bonding Agent |
| 16 Aug 2017 | K163568 | SHOFU RESIN GLAZE | EBD Resin Filling Material Coating |
| 11 Jan 2017 | K162261 | CERAMAGE UP | EBF Resin Tooth Shade Material |
| 21 Nov 2016 | K161891 | HC Primer | KLE Resin Tooth Bonding Agent |
| 27 Jul 2016 | K160596 | BEAUTIFIL II LS | EBF Resin Tooth Shade Material |
| 21 Jul 2016 | K160086 | SHOFU Enamel Conditioner | EBF Resin Tooth Shade Material |
| 2 Mar 2016 | K151700 | BEAUTIFIL II Gingiva | EBF Resin Tooth Shade Material |
| 8 Jan 2016 | K152392 | VINTAGE LD | EIH Porcelain Powder |
| 11 Dec 2015 | K152451 | VINTAGE Art LF | EIH Porcelain Powder |
| 10 Dec 2015 | K151699 | BEAUTIFIL II Enamel | EBF Resin Tooth Shade Material |
| 4 Dec 2013 | K132748 | BEAUTIFIL E POSTERIOR, BEAUTIFIL BULK | EBF Resin Tooth Shade Material |
| 3 Oct 2013 | K132141 | BEAUTIFIL BULK FLOWABLE | EBF Resin Tooth Shade Material |
| 11 Sep 2013 | K130841 | SHOFU BLOCK HC | EBF Resin Tooth Shade Material |
| 16 Jul 2013 | K131504 | UNIVERSAL OPAQUE | EBF Resin Tooth Shade Material |
| 16 May 2013 | K122614 | VINTAGE MP PRESS OVER | EIH Porcelain Powder |
| 26 Apr 2013 | K122908 | PRG BARRIER COAT | LBH Cavity Varnish |
| 28 Nov 2012 | K123119 | CERARESIN BOND | KLE Resin Tooth Bonding Agent |
| 7 Sep 2012 | K121749 | VERACIA | ELM Teeth Plastic Denture |
| 18 Jun 2012 | K120159 | BEAUTICEM SA | EMA Dental Cement |
| 28 Mar 2012 | K112307 | RESIGLASS PASTE | EMA Dental Cement |
| 8 Feb 2012 | K113426 | VERACIA SA | ELM Teeth Plastic Denture |
| 17 Nov 2011 | K111855 | HY-BOND RESIGLASS | EMA Dental Cement |
| 16 Sep 2011 | K111782 | BEAUTISEALANT | EBC Pit and Fissure Sealant and Conditioner |
| 2 Sep 2011 | K111685 | IP TEMP CEMENT | EMA Dental Cement |
| 13 May 2011 | K110252 | BEAUTIBOND MULTI PR PLUS | KLE Resin Tooth Bonding Agent |
| 13 May 2011 | K110235 | BEAUTIBOND MULTI | KLE Resin Tooth Bonding Agent |
| 23 Aug 2010 | K101621 | LITE ART | EBF Resin Tooth Shade Material |
| 23 Aug 2010 | K101603 | BEAUTIFIL FLOW PLUS | EBF Resin Tooth Shade Material |
| 3 Mar 2010 | K093559 | VINTAGE MP | EIH Porcelain Powder |
| 11 Dec 2008 | K082744 | BEAUTIBOND | KLE Resin Tooth Bonding Agent |
| 11 Jun 2008 | K080834 | VINTAGE ART | EIH Porcelain Powder |
| 11 Jun 2008 | K080517 | RESICEM | EMA Dental Cement |
| 28 Feb 2008 | K080068 | BEAUTIFIL OPAQUER | EBF Resin Tooth Shade Material |
| 15 Aug 2007 | K071742 | BEAUTIFIL II | EBF Resin Tooth Shade Material |
| 9 Jul 2007 | K071452 | FL BOND II | KLE Resin Tooth Bonding Agent |
| 18 Nov 2005 | K052033 | VINTAGE ZR | EIH Porcelain Powder |
| 3 Aug 2005 | K051818 | BEAUTIFIL FLOW | EBF Resin Tooth Shade Material |
| 28 Apr 2005 | K050401 | CERAMAGE | EBF Resin Tooth Shade Material |
| 9 Sep 2004 | K040079 | M.L. PRIMER | KLE Resin Tooth Bonding Agent |
| 5 Feb 2004 | K032416 | VINTAGE PRESS, VINTAGE LF, VINTAGE LF STAIN | EIH Porcelain Powder |
| 16 Sep 2003 | K032165 | VINTAGE AL | EIH Porcelain Powder |
| 17 Jul 2003 | K031467 | GLASIONOMER FX-II | EMA Dental Cement |
| 20 Jun 2002 | K021613 | NIVEOUS LIQUID DAM | EIE Rubber Dam |
| 20 Apr 2001 | K010914 | BEAUTIFIL | EBF Resin Tooth Shade Material |
| 26 Sep 2000 | K002461 | HY-BOND POLYCARBOXYLATE TEMPORARY DENTAL CEMENT | EMA Dental Cement |
| 24 Aug 1998 | K982461 | GLASIONOMER CEMENT CX PLUS | EMA Dental Cement |
| 29 Oct 1997 | K972292 | SOLIDEX | EBF Resin Tooth Shade Material |
| 16 Oct 1997 | K973247 | VINTAGE HALO | EIH Porcelain Powder |
| 30 Jun 1997 | K971927 | HI DENSE TC | EMA Dental Cement |
| 4 Oct 1995 | K953613 | IMPERVA ENSURABOND | KLE Resin Tooth Bonding Agent |
| 4 Oct 1995 | K953612 | IMPERVA FLUOROBOND | KLE Resin Tooth Bonding Agent |
| 27 Feb 1995 | K945451 | HI DENSE, GLASS IONOMER SILVER REINFORCED RESTORATIVE | EMA Dental Cement |
| 2 May 1994 | K940122 | HY BOND, GLASIONOMER CX | EMA Dental Cement |
| 1 Sep 1992 | K920893 | LITE FILL II P | EBF Resin Tooth Shade Material |
| 1 Sep 1992 | K920892 | LITE FIL II A | EBF Resin Tooth Shade Material |
| 3 Dec 1991 | K913946 | IMPERVA DUAL | KLE Resin Tooth Bonding Agent |
| 9 Oct 1991 | K913947 | IMPERVA BOND | EBF Resin Tooth Shade Material |
| 14 Aug 1990 | K896071 | ULTRA II PORCELAIN POLISHING PASTE | EJR Oral Cavity Abrasive Polishing Agent |
| 14 Jul 1989 | K893481 | CRYSTAR(TM) ANTI-GREENING LIQUID | ELL Porcelain Teeth |
| 8 Dec 1988 | K884214 | CRYSTAR(TM) VINTAGE PORCELAIN | ELL Porcelain Teeth |
| 21 Jul 1987 | K871899 | IMPERVA-A | EBF Resin Tooth Shade Material |
| 21 Jul 1987 | K871898 | IMPERVA-P | EBF Resin Tooth Shade Material |
| 26 Aug 1986 | K863141 | KULZER GLASS IONOMER LINER | EMA Dental Cement |
| 23 Jun 1986 | K862280 | SHOFU LINING CEMENT | EMA Dental Cement |
| 25 Apr 1986 | K861005 | GLASIONOMER BASE CEMENT | EMA Dental Cement |
| 27 Dec 1985 | K854347 | HYBRID POINTS | DZP Dental Diamond Instrument |
| 10 Apr 1985 | K850913 | GLAS IONOMER CEMENT | EMA Dental Cement |
| 3 Dec 1984 | K843901 | ISOSTATIC CONDENSER | EKG Operative Amalgam and Foil Condenser |
| 14 May 1984 | K841195 | GLAS IONOMER CEMENT | EMA Dental Cement |
| 11 May 1984 | K841196 | HY-BOND ZINC OXIDE EUGENOL TEMP. | EMA Dental Cement |
| 25 Apr 1984 | K840873 | CRYSTAR PORCELAIN MARGIN POWDER/LIQUID | EIH Porcelain Powder |
| 6 Mar 1984 | K834497 | SHOFU PORCELAIN STAIN | EIH Porcelain Powder |
| 29 Dec 1983 | K833643 | CRYSTAR PORCELAIN | EIH Porcelain Powder |
| 4 Oct 1983 | K833039 | HANDY IIM | EJP Articulators |
| 4 Oct 1983 | K833038 | SUMMA DISK | DZP Dental Diamond Instrument |
| 4 Oct 1983 | K832856 | GINGI CURETTAGE DIAMOND POINTS | DZP Dental Diamond Instrument |
| 29 Sep 1983 | K832855 | TPE DIAMOND POINTS | DZP Dental Diamond Instrument |
| 26 Jun 1981 | K811013 | SUMMAR NON-PRECIOUS, CERAMIC ALLOY | EJH Base Metal Alloy |
| 12 Jun 1981 | K810765 | HY-BOND ZINC PHOSPHATE CEMENT | EMA Dental Cement |
| 12 Jun 1981 | K810764 | HY-BOND POLYCARBOXYLATE CEMENT | EMA Dental Cement |
| 24 Mar 1981 | K810594 | CRYSTALLOY-P | EJH Base Metal Alloy |
Some of these clearances are listed with FDA today by another company: Advanced Healthcare , Ltd. (5).
Also lists devices cleared under other names
Shofu Inc lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Topzir Biotech Co., Ltd (1), New Stetic, SA (1), Adamant Co., Ltd. (1), Bicon, LLC (1), Pulpdent Corporation (1), Nsk Nakanishi, Inc. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 31 Mar 2023 | K230003 | Topzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank | Topzir Biotech Co., Ltd | EIH Porcelain Powder |
| 7 Nov 2019 | K192153 | Portux CAD/CAM Disc | New Stetic, SA | EBG Resin Temporary Crown and Bridge |
| 19 Oct 2016 | K160203 | ADAMANT ZIRCONIA DISC | Adamant Co., Ltd. | EIH Porcelain Powder |
| 2 Jun 2015 | K143524 | Fiber Disks and Blocks (TRINIA) | Bicon, LLC | EBF Resin Tooth Shade Material |
| 17 Apr 2002 | K020481 | PULPDENT POST CEMENT | Pulpdent Corporation | EMA Dental Cement |
| 24 Sep 1996 | K962542 | AIR MOTOR HANDPIECE TN-102 | Nsk Nakanishi, Inc. | EFB Dental Air-Powered Handpiece |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| SHANGHAI SHOFU DENTAL MATERIAL CO. LTDFDA reg. 3006942526 | Shanghai, China | Contract manufacturer |
| SHIGA SHOFU INC.FDA reg. 3011814610 | Koka Shiga, Japan | Contract manufacturer |
| SHOFU DENTAL CORP.FDA reg. 2916735 | SAN MARCOS, CA, United States | Repacker / relabeler |
| SHOFU INC.FDA reg. 3002808149 | FUKUINE, HIGASHIYAMA-KU Kyoto, Japan | Foreign exporter, Manufacturer, Repacker / relabeler |
| SHOFU PRODUCTS KYOTO INC.FDA reg. 3013526557 | Kyoto, Japan | Manufacturer |
| SHOFU PRODUCTS VIETNAM CO., LTDFDA reg. 3031601673 | Dong Van Ward Ninh Binh, Vietnam | Contract manufacturer |
Other names on FDA records
Shofu Dental Corporation · Shanghai Shofu Dental Material Co., Ltd. · Shiga Shofu Inc. · Shofu Products Kyoto Inc. · Shofu Products Vietnam Co., Ltd.
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9056340). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.