Company ยท US
Shofu Dental Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1981 to 2025. Name variants (Inc, Corp, punctuation) are merged.
97510(k) clearances (1 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| EBF | Material, Tooth Shade, Resin | 27 |
| EMA | Cement, Dental | 24 |
| EIH | Powder, Porcelain | 15 |
| KLE | Agent, Tooth Bonding, Resin | 13 |
| DZP | Instrument, Diamond, Dental | 4 |
| EJH | Alloy, Metal, Base | 2 |
| ELL | Teeth, Porcelain | 2 |
| ELM | Denture, Plastic, Teeth | 2 |
| EBC | Sealant, Pit And Fissure, And Conditioner | 1 |
| EBD | Coating, Filling Material, Resin | 1 |
| EIE | Dam, Rubber | 1 |
| EJP | Articulators | 1 |
| EJR | Agent, Polishing, Abrasive, Oral Cavity | 1 |
| EKG | Condenser, Amalgam And Foil, Operative | 1 |
| FHJ | Shield, Circumcision | 1 |
| LBH | Varnish, Cavity | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 9, 2025 | K252808 | GlasIonomer FX-LC Shofu Dental Corporation | EMA |
| Oct 28, 2025 | K252165 | ZIRCONOMER P Shofu Dental Corporation | EMA |
| Jul 11, 2025 | K251470 | ResiCem EX Shofu Dental Corporation | EMA |
| May 27, 2025 | K251578 | BEAUTIFIL II Shofu Dental Corporation | EBF |
| Sep 28, 2023 | K233161 | BeautiLink SA Shofu Dental Corporation | EMA |
| Sep 22, 2022 | K222253 | GlasIonomer FX ULTRA Shofu Dental Corporation | EMA |
| Mar 18, 2022 | K213965 | BeautiBond Xtreme Shofu Dental Corporation | KLE |
| Mar 18, 2022 | K212939 | Vintage Prime Press Shofu Dental Corporation | EIH |
| Feb 5, 2021 | K200470 | Shofu Block HC Hard Shofu Dental Corporation | EBF |
| Oct 3, 2019 | K191794 | Vintage Art Universal Shofu Dental Corporation | EIH |
| Jan 9, 2019 | K182869 | Fit SA Shofu Dental Corporation | EBF |
| Dec 18, 2018 | K181496 | VINTAGE PRO Shofu Dental Corporation | EIH |
| Sep 26, 2018 | K180803 | BeautiBond Universal Shofu Dental Corporation | KLE |
| Jun 11, 2018 | K180649 | BeautiCem Veneer Kit Shofu Dental Corporation | EBF |
| Dec 6, 2017 | K172530 | BEAUTIFIL Flow Plus X Shofu Dental Corporation | EBF |
| Aug 31, 2017 | K172106 | SHOFU MZ Primer Plus Shofu Dental Corporation | KLE |
| Aug 16, 2017 | K163568 | SHOFU RESIN GLAZE Shofu Dental Corporation | EBD |
| Jan 11, 2017 | K162261 | CERAMAGE UP Shofu Dental Corporation | EBF |
| Nov 21, 2016 | K161891 | HC Primer Shofu Dental Corporation | KLE |
| Jul 27, 2016 | K160596 | BEAUTIFIL II LS Shofu Dental Corporation | EBF |
| Jul 21, 2016 | K160086 | SHOFU Enamel Conditioner Shofu Dental Corporation | EBF |
| Mar 2, 2016 | K151700 | BEAUTIFIL II Gingiva Shofu Dental Corporation | EBF |
| Jan 8, 2016 | K152392 | VINTAGE LD Shofu Dental Corporation | EIH |
| Dec 11, 2015 | K152451 | VINTAGE Art LF Shofu Dental Corporation | EIH |
| Dec 10, 2015 | K151699 | BEAUTIFIL II Enamel Shofu Dental Corporation | EBF |
| Dec 4, 2013 | K132748 | BEAUTIFIL E POSTERIOR, BEAUTIFIL BULK Shofu Dental Corporation | EBF |
| Oct 3, 2013 | K132141 | BEAUTIFIL BULK FLOWABLE Shofu Dental Corporation | EBF |
| Sep 11, 2013 | K130841 | SHOFU BLOCK HC Shofu Dental Corporation | EBF |
| Jul 16, 2013 | K131504 | UNIVERSAL OPAQUE Shofu Dental Corporation | EBF |
| May 16, 2013 | K122614 | VINTAGE MP PRESS OVER Shofu Dental Corporation | EIH |
| Apr 26, 2013 | K122908 | PRG BARRIER COAT Shofu Dental Corporation | LBH |
| Nov 28, 2012 | K123119 | CERARESIN BOND Shofu Dental Corporation | KLE |
| Sep 7, 2012 | K121749 | VERACIA Shofu Dental Corporation | ELM |
| Jun 18, 2012 | K120159 | BEAUTICEM SA Shofu Dental Corporation | EMA |
| Mar 28, 2012 | K112307 | RESIGLASS PASTE Shofu Dental Corporation | EMA |
| Feb 8, 2012 | K113426 | VERACIA SA Shofu Dental Corporation | ELM |
| Nov 17, 2011 | K111855 | HY-BOND RESIGLASS Shofu Dental Corp. | EMA |
| Sep 16, 2011 | K111782 | BEAUTISEALANT Shofu Dental Corporation | EBC |
| Sep 2, 2011 | K111685 | IP TEMP CEMENT Shofu Dental Corporation | EMA |
| May 13, 2011 | K110252 | BEAUTIBOND MULTI PR PLUS Shofu Dental Corp. | KLE |
| May 13, 2011 | K110235 | BEAUTIBOND MULTI Shofu Dental Corp. | KLE |
| Aug 23, 2010 | K101621 | LITE ART Shofu Dental Corp. | EBF |
| Aug 23, 2010 | K101603 | BEAUTIFIL FLOW PLUS Shofu Dental Corp. | EBF |
| Mar 3, 2010 | K093559 | VINTAGE MP Shofu Dental Corp. | EIH |
| Dec 11, 2008 | K082744 | BEAUTIBOND Shofu Dental Corp. | KLE |
| Jun 11, 2008 | K080834 | VINTAGE ART Shofu Dental Corp. | EIH |
| Jun 11, 2008 | K080517 | RESICEM Shofu Dental Corp. | EMA |
| Feb 28, 2008 | K080068 | BEAUTIFIL OPAQUER Shofu Dental Corp. | EBF |
| Aug 15, 2007 | K071742 | BEAUTIFIL II Shofu Dental Corp. | EBF |
| Jul 9, 2007 | K071452 | FL BOND II Shofu Dental Corp. | KLE |
Newest 50 of 97.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||